Apparatus and methods for loading suture

ABSTRACT

Various embodiments of a cartridge are disclosed, for loading a suture onto a suturing instrument and, in some embodiments, for loading a pre-tied knot formed from the suture onto the suturing instrument. The suturing instrument is typically of the type having a suture passing member defining a suture receiving passage therein. The cartridge may be operable to load the suture and/or the knot onto the suturing instrument at a point of use. In some embodiments, the cartridge defines a path for insertion thereto and withdrawal therefrom of the suturing instrument. The cartridge further comprises a seat for releasably holding a portion of a suture and a mechanism for transferring the suture from seat to the suturing instrument, various features of which are described herein.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/126,197 filed Sep. 14, 2016, which is a national phase entry ofinternational application PCT/IB2014/064608, filed Sep. 17, 2014, whichis a continuation in part of international application PCT/IB2014/059847filed Mar. 15, 2014.

TECHNICAL FIELD

The disclosure relates to an apparatus for loading suture onto a medicaldevice, more specifically, to cartridge for loading suture onto asurgical suturing instrument.

SUMMARY OF THE DISCLOSURE

Various embodiments of a cartridge are disclosed, for loading a sutureonto a suturing instrument and, in some embodiments, for loading apre-tied knot formed from the suture onto the suturing instrument. Thesuturing instrument is typically of the type having a suture passingmember defining a suture receiving passage therein. The cartridge may beoperable to load the suture and/or the knot onto the suturing instrumentat a point of use. In some embodiments, the cartridge defines a path forinsertion thereto and withdrawal therefrom of the suturing instrument.The cartridge further comprises a seat for releasably holding a portionof a suture and a mechanism for transferring the suture from seat to thesuturing instrument, various features of which are described herein.

In one broad aspect, embodiments of the present invention provide acartridge for loading a suture onto a suturing instrument, the cartridgedefining a path for insertion thereto and withdrawal therefrom of thesuturing instrument, the cartridge comprising: a seat for releasablyholding a portion of a suture; and a translation mechanism for movingthe seat out of a path of a suturing instrument inserted into thecartridge to allow for withdrawal of the suturing instrument from thecartridge.

In another broad aspect, embodiments of the present invention provide acartridge for loading a suture onto a suturing instrument, the cartridgecomprising: a seat for releasably holding a portion of a suture; and analignment feature for facilitating alignment of the seat with a suturinginstrument to permit transfer of the suture portion from the seat ontothe suturing instrument.

In still an additional broad aspect, embodiments of the presentinvention provide A cartridge for loading suture onto a suturinginstrument, the cartridge comprising: a seat for holding a portion ofthe suture; and an instrument retention mechanism configured to allowadvancement of a suturing instrument into the cartridge and to preventpremature retraction therefrom.

In a further broad aspect embodiments of the present invention comprisea cartridge for loading a suture onto a suturing instrument, thecartridge comprising: a seat for releasably holding a portion of asuture to enable transfer of the suture onto the suturing instrument;and an indicator for indicating transfer of the suture portion onto thesuturing instrument.

In still an additional embodiment, a cartridge is provided for loadingsuture onto a suturing instrument, the cartridge comprising: a seat forholding a portion of a suture; and an obstructing feature having aclosed configuration and an open configuration, the obstructing featurebeing configured to be initially in the closed configuration forpreventing advancement of an inverted suturing instrument into thecartridge, and to be moveable into the open configuration upon insertionof the suturing instrument into the cartridge in a nominal orientation.

In still another broad aspect, embodiments of the present inventionprovide a cartridge for loading suture onto a suturing instrument, thecartridge comprising: a seat for releasably holding a portion of thesuture; an alignment feature for aligning the seat with a portion of thesuturing instrument; a suture insertion mechanism that is actuatable toinsert the suture portion from the seat onto the suturing instrument;and a delay interlock to prevent actuation of the suture insertionmechanism prior to alignment of the seat with the portion of thesuturing instrument.

In still another broad aspect, embodiments of the present inventionprovide a cartridge for In still a further broad aspect, embodiments ofthe present invention provide a cartridge for loading a pre-tied knotonto a suturing instrument, the cartridge comprising: a cartridgehousing; a knot slider for carrying a pre-tied knot thereabout; and aknot slider release mechanism for detachably coupling the knot slider tothe cartridge housing.

In an additional broad aspect, embodiments of the present inventionprovide a cartridge for a cartridge for loading suture onto a suturinginstrument comprising a suture passing member, the cartridge comprisinga seat for holding an end of the suture, the seat being structured andconfigured to allow a suture passing member to be advanced over thesuture end to capture the suture end.

Furthermore, as an additional broad aspect of the present invention,embodiments of a kit are provided, the kit generally including at leastone cartridge as described hereinbelow, along with at least one suturinginstrument, the cartridge being operable in cooperation with thesuturing instrument to load suture from the cartridge onto theinstrument.

BRIEF DESCRIPTION OF THE DRAWINGS

In order that the invention may be readily understood, embodiments ofthe invention are illustrated by way of examples in the accompanyingdrawings, in which:

FIG. 1A illustrates a left side perspective view of a cartridge, inaccordance with an embodiment of the present invention;

FIG. 1B illustrates a right side view of a cartridge in accordance withan embodiment of the present invention;

FIG. 1C illustrates a left side view of a portion of a surgical suturinginstrument for use with a cartridge in accordance with an embodiment ofa the present invention;

FIG. 1D illustrates a right side view of a portion of surgical suturinginstrument for use with a cartridge in accordance with an embodiment ofthe present invention;

FIG. 1E illustrates a cross-sectional view of a portion of the surgicalsuturing for use with a cartridge in accordance with an embodiment ofthe present invention;

FIG. 1F illustrates a left side view of a cartridge mounted onto asurgical suturing instrument in accordance with an embodiment of thepresent invention;

FIG. 2A illustrates a cross-sectional view of a cartridge, in accordancewith an alternate embodiment of the present invention;

FIG. 2B illustrates a cross-sectional view of a cartridge with asurgical suturing instrument partially advanced therein, in accordancewith an embodiment of the present invention;

FIG. 2C illustrates a cross-sectional view of a cartridge with asurgical suturing instrument advanced therein, in accordance with anembodiment of the present invention;

FIGS. 3A-3O illustrate views of a cartridge in accordance with analternate embodiment of the present invention;

FIGS. 4A-4D illustrate views of a cartridge and a method of using thesame in accordance with an embodiment of the present invention;

FIGS. 5A-5C illustrate views of an interlock mechanism of a cartridge inaccordance with an embodiment of the present invention;

FIGS. 6A-6B illustrate views of an interlock mechanism of a cartridge inaccordance with an embodiment of the present invention;

FIGS. 7A-7F illustrate views of a suture lock mechanism of a cartridgein accordance with an embodiment of the present invention;

FIGS. 8A-8H(ii) illustrate views of a cartridge in accordance with analternate embodiment of the present invention;

FIGS. 9A(i)-9F illustrate views of a cartridge and a method of using thesame in accordance with an alternate embodiment of the presentinvention;

FIGS. 10A-10D(ii) illustrate views of a cartridge and a method of usingthe same in accordance with an alternate embodiment of the presentinvention;

FIGS. 11A-11D illustrate views of a knot slider of a cartridge a methodof using the same in accordance with an alternate embodiment of thepresent invention;

FIGS. 12A-12F illustrate a side loading alignment mechanism of acartridge and a method of using the same in accordance with an alternateembodiment of the present invention;

FIGS. 13A-13L illustrate views of a cartridge in accordance with analternate embodiment of the present invention;

FIGS. 14A-14G illustrate views of a rocker in accordance with alternateembodiments of the present invention;

FIGS. 15A(i)-15C(iii) illustrate a cartridge comprising an instrumentretention mechanism in accordance with an embodiment of the presentinvention;

FIGS. 16A-16D illustrate a cartridge comprising an instrument retentionmechanism in accordance with an alternate embodiment of the presentinvention;

FIGS. 17A-17C(ii) illustrate a still further alternative for aninstrument retention mechanism for a cartridge in accordance with anembodiment of the present invention;

FIGS. 18Ai)-18F illustrate a cartridge and method of use thereof inaccordance with an embodiment of the present invention;

FIGS. 19A-19C illustrate an alternate embodiment of a cartridge knotslider comprising a feature to prevent upside-down (reverse-oriented)insertion of the suturing instrument, in accordance with an embodimentof the present invention;

FIGS. 20A-20B illustrate an alternate embodiment of an interlock forpreventing upside-down (reverse-oriented) insertion of the suturinginstrument, in accordance with an embodiment of the present invention;

FIGS. 21Ai)-21Bii) illustrate an alternate embodiment of an interlockfor preventing upside-down (reverse-oriented) insertion of the suturinginstrument, in accordance with an embodiment of the present invention;

FIGS. 21C-21E illustrate alternate embodiments of an interlock forpreventing upside-down (reverse-oriented) insertion of the suturinginstrument, in accordance with various embodiments of the presentinvention;

FIGS. 22A-22E illustrate various views of a knot slider comprising anattachment mechanism for slidably engaging with the suturing instrument;

FIG. 22F illustrates a view of a knot slider comprising a feature tofacilitate sliding of the knot slider on the suturing instrument;

FIGS. 23A-23G illustrate various views of an alternate embodiment of acartridge for facilitating capture of a suture portion by a suturepassing member, in accordance with an embodiment of the presentinvention; and

FIGS. 24Ai)-24Cii) illustrate various alternative of a cartridge inaccordance with alternative embodiments of the present invention.

DETAILED DESCRIPTION

In certain medical interventional procedures, a suturing instrument maybe used by physicians to pass suture through a region of tissue having acut or a defect in order to approximate the tissue to repair the defect.In some such procedures, there may be a need to load suture onto thesurgical suturing instrument at the point of use. However, it may bedifficult to load the suture using conventional loading mechanisms asthey may require the user to perform several steps, may require userdexterity, concentration and a specific order of operation which if doneout of order could result in a failure of the device and may be timeconsuming. Thus, there is a need in the art to provide a cartridge forloading suture onto a suturing instrument at the point of use thatprovides ease of use and which allows the suture to be loaded in anefficient manner.

The present inventors have discovered, and reduced to practice, severalembodiments of a novel apparatus and method that facilitates loading ofsuture onto a suturing instrument at the point of use. In general, inaccordance with embodiments of the present invention, a cartridge isprovided that permits loading of a suture onto a suturing instrumentupon axial or linear movement of the suturing instrument at leastpartially through the cartridge. The cartridge may additionally compriseone or more features that facilitate alignment and transferring of thesuture onto the instrument.

More specifically, some embodiments of the present invention provide asuture cartridge that is usable for loading suture onto a medical devicesuch as a surgical suturing instrument at the point of use in asituation where suture is to be supplied separate from the device. Insome such embodiments of the present invention, a cartridge is providedthat allows the physician to load the suture onto a surgical suturinginstrument prior to a surgical procedure using an axial or front endloading mechanism. The cartridge defines a seat for holding a portion ofthe suture and defines an opening extending longitudinally through atleast a portion of the cartridge, which allows a portion of the surgicalsuturing instrument to be received axially there-through for aligning aportion of the suture held therein with the surgical suturinginstrument. This allows direct transfer of the portion of the sutureheld within the seat from the cartridge onto the surgical suturinginstrument, allowing it to be independently transferred to enable thesurgical suturing instrument to suture therewith.

In some embodiments of the present invention, the cartridge mayadditionally comprise one or more features that facilitate transferringor loading the suture onto the device.

In some embodiments, the cartridge additionally provides one or more of:a means to mount a pre-tied knot onto the surgical instrument, arestraint to secure a position of the suturing instrument upon insertioninto the cartridge, and an alignment feature to align the suture withthe suturing instrument, such as a moveable seat. In some suchembodiments, a cartridge is provided that is usable with a suturinginstrument that defines a tissue receiving gap, where the cartridge isconfigured to position the seat within the tissue receiving gap tofacilitate alignment of the portion of the suture held within the seatwith a suture passing member of the suturing instrument.

Certain embodiments of the present invention thereby provide a suturecartridge for loading suture onto a suturing instrument, for example ata point of use, by efficiently aligning the suture with the suturinginstrument. In some embodiments, the cartridge additionally provides oneor more of a means to load a pre-tied knot onto a suturing instrumentand a means for transferring the suture onto the suturing instrument.

Furthermore, several novel embodiments of methods for loading a sutureonto a suturing instrument are described hereinbelow. In addition,methods of suturing tissue of an intervertebral disc including acartridge for loading the suture onto a suturing instrument, aredescribed as well.

With specific reference now to the drawings in detail, it is stressedthat the particulars shown are by way of example and for purposes ofillustrative discussion of certain embodiments of the present inventiononly. Before explaining at least one embodiment of the invention indetail, it is to be understood that the invention is not limited in itsapplication to the details of construction and the arrangement of thecomponents set forth in the following description or illustrated in thedrawings. The invention is capable of other embodiments or of beingpracticed or carried out in various ways. Also, it is to be understoodthat the phraseology and terminology employed herein is for the purposeof description and should not be regarded as limiting.

Example 1A

In accordance with an embodiment of the present invention a suturecarrying cartridge is provided for loading a surgical suturinginstrument such as a suture passer at the point of use (where thesuturing instrument requires a pre-tied knot and comprises a suturepassing member, and where loading involves loading the suture onto thesuture passing member and loading the pre-tied knot onto the surgicalsuturing instrument). The suture carrying cartridge (having a pre-tiedknot secured thereto) is coupled to the suture passer and allowscoupling of the suture to the suture passing member by allowing thesuture to be moved so that it is aligned with the suture passing member.

FIG. 1A further illustrates a cartridge 100 in accordance with anembodiment of the present invention. The cartridge 100 is provided forloading a length of suture 500 onto a surgical suturing instrumentincluding loading a pre-tied knot 502 comprising suture loops (which insome embodiments is formed from and/or attached to the suture 500) ontothe suturing instrument. In exemplary embodiment shown, the suture 500may define an end portion 504 (of the suture (or suture end) 504, suchas a knot 504′), for loading onto the surgical suturing instrument 900.As shown in FIG. 1B, the suture 500 emanating from the pre-tied knot 502terminates in two strands of suture: a service loop 501 terminating intug loop 507 that is connected to the suture end 504, and a locker 503.In some embodiments the surgical suturing instrument is of the typedefining a suture passing member defining a suture receiving passagetherein for receiving the end portion 504 of the suture 500 from thecartridge 100.

In one example as illustrated in FIGS. 1C and 1D the surgical suturingInstrument or suturing instrument 900 is of the type having anInstrument proximal portion (or shaft) 910 and an Instrument distalportion 920 coupled thereto via a neck portion 940 and defining a tissuereceiving gap 942 there-between. The instrument distal portion 920 mayalternatively be referred to as the distal end or distal tip 920. Asshown in the cross-sectional view of FIG. 1E, the suturing instrument900 comprises a suture passing member 930 such as a hollow needle 930′housed within the instrument proximal portion 910, the suture passingmember 930 defining a suture receiving passage 932 for receiving the endportion 504 of the suture. In some embodiments, the suture passingmember 930 is reciprocally movable for example, between the deviceproximal portion 910 and the device distal portion 920. In someembodiments movement of the suture passing member 930 may assist intransferring the suture end portion 504 from the cartridge 100 to thesuturing instrument 900. In a particular example the suturing instrument900 is of the type shown and described in the PCT application:PCT/IB2012/054204, which is incorporated herein by reference in itsentirety.

Referring again to the exemplary embodiment shown in FIG. 1A, acartridge 100 is shown for loading suture 500 onto the surgical suturinginstrument 900. In accordance with a general embodiment of the presentinvention, the cartridge 100 comprises a housing 10′ defining a chamber10 for receiving the surgical suturing instrument 900. The cartridgefurther comprises a base 120 coupled to the chamber 10.

In the specific example shown in FIG. 1A, the chamber 10 comprises ameans for securing or mounting the pre-tied knot 502 about the chamber10. In the illustrated embodiment, the means for securing the pre-tiedknot 502 comprises a mount 12 for holding the pre-tied knot 502 aboutthe chamber 10. More specifically, the mount 12 may form a part of thehousing 10′. Additionally, the chamber 10 defines a channel to allow aportion of the suturing instrument 900 to be received through thepre-tied knot 502 to enable the pre-tied knot 502 to be deployedthereon.

In the exemplary embodiment shown in FIG. 1A, the base 120 defines aseat 122 for releasably holding a portion of a suture 500, such as anend 504 of the suture 500. In the specific example shown, the seat 122defines a seat channel (recess or passage) 124 for retaining the sutureend 504. More specifically, the cartridge 100 specifies a seat 122 for‘directly holding’ the end 504 of the suture 500 such the suture 500 byitself is held directly by the seat 122.

In accordance with a broad embodiment of the present invention, thecartridge 100 is structured to allow the seat 122 to be brought intoalignment with and in some examples adjacent the suture receivingpassage 932 of the suture passing member 930. In some embodiments, aswill be discussed herein below with respect FIG. 1F, the seat 122 ismoveable (along with the base 120) relative to the chamber 10 andhousing 10′ to bring the suture end 504 into alignment with the suturereceiving passage 932.

In some embodiments of the present invention as shown in FIG. 1A, thecartridge 100 includes an alignment feature that restrains orfixes/locks the position of the suturing instrument 900 relative to thecartridge to help align the seat 122 with suture receiving passage 932of the of the suture passing member 930 such as a needle 930′. Morespecifically, the cartridge base 120 comprises a restraint 25 (means forrestraining) for positioning a portion of the suturing instrument 900received through the chamber 10 relative to the seat 122 for aligningthe seat 122 with a suture receiving passage 932 of the suture passingmember 930. In some embodiments, the restraint may function as a meansfor locking or snapping the cartridge 100 onto the suturing instrument,such as a locking feature. In the embodiment illustrated in FIG. 1A, therestraint 25 comprises a recess that functions as a locking recess 125for receiving a portion of the surgical suturing instrument 900. Asshown in FIG. 1F, the locking recess 125 receives the suturinginstrument 900 and allows the base 120 of the cartridge 100 to belatched onto the suturing instrument 900. In other words, the lockingrecess 125 within the base 120 receives a portion of the surgicalsuturing instrument 900 (neck portion 940 and sections of the proximaland distal portions 910, 920) such that the base 120 press-fits aroundthe portion of the suturing instrument 900, to lock the position of thesurgical suturing instrument 900 relative to the base 120.

As shown in FIG. 1A, the cartridge 100 additionally comprises analignment feature in the form of an alignment recess 130 locatedadjacent the seat 122. In a specific example, as shown in FIG. 1F, thealignment recess 130 is sized to allow the suture passing member 930 tobe advanced therein to allow the suture receiving passage 932 to bealigned with the seat 122. As shown in FIG. 1F, the alignment recess 130additionally comprises a bevel face 134 that matches the bevel face 934of the needle 930′ to further assist in aligning the needle 930′ withthe seat 122. Thus in the exemplary embodiment, the alignment recess 130receives a portion of the suture passing member 930 such as needle 930′when it is advanced distally to allow the suture receiving passage 932to be placed in line with the suture end 504 held within the seat 122.This permits suture 500 to be loaded onto the suturing instrument 900,for example by allowing the tug loop 507 (that is connected to the endportion 504 of the suture 500) to be pulled to transfer the suture end504 from the cartridge 100 into the suture receiving passage 932. Thealignment recess 130 allows the seat 122 to be brought adjacent and incommunication with the suture receiving passage 932 to allow the sutureend 504 to be transferred into the lumen of the suture passing member930.

The cartridge may additionally comprise features to assist in routing ofthe suture 500 to facilitate manipulation of the suture 500 in order totransfer the suture 500 from the cartridge 100 to the surgical suturinginstrument 900. With reference now to FIGS. 1B and 1E, in someembodiments the base 120 of the cartridge 100 further defines a basechannel or base slot 128 in communication with the seat 122 for routingthe suture 500 to facilitate manipulation of the suture 500 in order toload the suture 500 onto/within the suture passing member 930. In someembodiments, once the cartridge 100 is loaded onto the suturinginstrument 900, the base slot 128 may be aligned with a longitudinalopening 928 within the suturing instrument 900 (for example, within theinstrument proximal portion 910). In some embodiments, the suturepassing member 930 may also comprise a slit 938 that can line up withthe base slot 128 so that it is in communication with the base slot 128.This facilitates loading of the suture 500 into the suture receivingpassage 932 by allowing room for suture 500 to exit the cartridge 100,so that it may be manipulated, for example by tugging on the suture 500to allow it to be transferred from the seat 122 to within the suturepassing member 930.

In some embodiments, the cartridge 100 may comprise a base 120 that isformed integrally with the chamber 10 or housing 10′. In otherembodiments, the base 120 may be detachably coupled to the housing 10′via a detachable coupling 50, as shown in FIG. 1A. This may allow thebase 120 to be decoupled to from the housing 10′ after suture end 504 isloaded into a suturing instrument using the cartridge 100. The housing10′ may then be advanced or slid proximally to position the housing 10′and pre-tied knot 502 thereon along the instrument proximal portion, topermit deployment of the pre-tied knot 502 after the suturing instrumentis used to apply suture to a region of tissue (such as aninter-vertebral disc) to help secure the suture 500 within the region oftissue.

In some such embodiments, with reference now to FIGS. 1A and 1B, thebase 120 is indirectly coupled to the housing 10′ through a flexiblecoupling 150 such as a flexible tube or tether 152. In some examples, afirst end of the flexible tube 152 may be affixed permanently to one ofthe base 120 and the housing 10′, whereas the a second end of theflexible tube 152 may be removably attached to the other of the base 120and the housing 10′. In the example shown, one end of the flexible tube152 is permanently secured to the base 120 within the base slot 128 andthe second end of the flexible tube 152 is received within a groove 16within the housing 10′ to be removably attached thereto. Alternatively,both ends of the flexible tube 152 could be permanently affixed to eachof the base 120 and the housing 10′ and the flexible tube 152 may bedesigned with break lines to allow separation of the flexible tube 152into two parts under application of force, allowing detachment of thebase 120 from the housing 10′. In another example, the flexible coupling150 may comprise a flexible or soft hinge. Alternatively, the base 120may be directly coupled to the housing 10′.

In some embodiments, the cartridge 100 may additionally comprise a meansto store the length of suture 500 such as suture storage 60, shown inFIG. 1B. The suture storage 60 may comprise one or more spools 160 heldwithin the cartridge 100 to store the length of suture 500. Morespecifically, the one or more spools 160 may be held within the housing10′ to store the service loop 501 and the locker 503 of the suture 500.The one or more spools 160 may help prevent entanglement of the suture500 during loading of the suturing instrument 900 and/or during use ofthe suturing instrument 900. Alternatively, the suture 500 may be heldwithin suture payout tubes.

Example 1B

Referring again to FIG. 1B, in some embodiments the cartridge 100comprises a suture retaining component 65 such as a suture retaining pin165 for retaining a portion of the suture 500 to allow the tug loop 507of the suture 500 to be pulled (to transfer the suture end 504 withinthe suture receiving passage 932 of the suture passing member 930) whileminimizing or preventing force from being applied to the service loop501. This may help prevent the service loop 501 from being pulled outprematurely from the suture storage 60. In the illustrated embodiment,the suture retention pin 165 is releasable which allows the housing 10′(and thus chamber 10) to be advanced independently from the base 120proximally along the proximal portion 910 of the surgical suturinginstrument 900 in order to place the housing 10′ in a position fordeployment of the pre-tied knot 502 carried thereon.

Example 2

In an alternate embodiment of the present invention, as shown in FIGS.2A-2C, a cartridge 400 is disclosed. Similar to cartridge 300, cartridge400 provides a seat 422 that is moveable relative to the chamber 10(housing 10′). Additionally, cartridge 400 incorporates a seat 422 thatis automatically moveable.

With reference now to FIG. 2A, a cartridge 400 is disclosed comprising acartridge base 420 that is coupled to a housing, for example a housing10′ of the type discussed previously herein above. In one example, thebase 420 may be detachably coupled to the housing 10′ (chamber 10). Base420 comprises a magazine 421 which defines the seat 422 for releasablyholding or retaining the suture end 504. More specifically, the magazine421 comprises a projection 430 which defines the seat 422. In a specificexample the seat 422 comprises a seat channel 424 and the suture end 504is press-fit within the seat channel.

In the embodiment shown in FIGS. 2A-2C, the cartridge 400 comprises analignment feature in the form of a restraint 25 comprising an instrumentreceiving recess or locking recess 425′ that allows the suturinginstrument 900 to be positioned within the base 420 to allow the seat422 to be aligned with the suture receiving passage 932. Additionallythe alignment comprises a moveable seat 422. The magazine 421 is mountedonto a spring 426 forming a spring biased interlock 421′ which isautomatically moveable upon advancement of the surgical suturinginstrument 900 within an instrument receiving recess 425′ of the base420. Movement of the interlock 421′ translates into a movement of theprojection 430 defining the seat 422. Thus the seat 422 is moveable uponadvancement of the suturing instrument 900 to bring the suture intoalignment with the suture receiving passage 932. Thus in someembodiments of the present invention, the magazine 421 comprises aspring biased translation mechanism.

More specifically, referring now to FIG. 4B, the spring biased interlock421′ is shown in its initial position 421A. As shown in FIG. 2C, theinterlock 421′ is moveable from its first or initial position 421A intoits second position 421B upon advancement of the suturing instrument 900within the instrument receiving recess 425′. Movement or depression ofthe interlock 421′ into its second position 421B allows the seat 422 tobe brought into alignment with the suture passing member 930 and thesuture receiving passage 932. More specifically, the interlock 421′comprises a ramp 423 (shown in FIGS. 2A, 2B) that is engaged by thedistal tip 920 of the instrument 900 as the suturing instrument 900 isadvanced to automatically move the interlock 421′. For example ramp 423is engaged by a tapered surface of the distal tip 920. As a result seat422 (defined by projection 430) is automatically moveable and travelsdownwards into the tissue receiving gap 942 to bring the seat 422 (andthus the suture end 504 it retains) into alignment with the suturereceiving passage 932 of the surgical suturing instrument 900. In otherwords, the (magazine 421) and thus seat 422 is automatically moveableupon relative movement between the cartridge base 420 and the surgicalsuturing instrument 900

In some embodiments, an additional alignment feature is provided tofurther aid in aligning the seat 422 with the suture receiving passage932. As mention previously, cartridge base 420 comprises a projection430 that defines the seat 422. The projection 430 extends into theinstrument receiving recess 425′ and defines an alignment feature. Theprojection 430 is capable of abutting against/mating with the suturepassing member 930 such as needle 930′ when brought into engagementtherewith. In the present embodiment illustrated in FIG. 2C, as thesurgical suturing instrument 900 is advanced, the magazine 421 movesdownwards into the tissue receiving gap. Magazine 421, and thusprojection 430 and the seat 422 it defines, all move proximally withrespect to the suturing instrument 900, so that the projection 430 abutsagainst the needle 930′ to align the seat 422 with the suture receivingpassage 932. More specifically, the projection 930 abuts against theneedle 930′ to co-operatively engage with and align the needle 930′ tobring the seat 422 into alignment with the suture receiving passage 932.The seat 422 is brought into communication with the suture receivingpassage 932. In the specific example shown in FIGS. 2B-2C, theprojection 430 defines a bevel face 434 for engaging with a bevel face934 of the needle 930′ for docking the needle 930′ to align the needle930′ with the seat 222 to permit transfer of the suture end 504 from theseat 222 into the suture receiving passage 932 of the needle 930′ forexample by pulling on the tug loop 507. Alternatively, in someembodiments, the suture end 504 may be transferred automatically fromthe seat 422 into the suture receiving passage 932 for example using aplunger.

In one particular embodiment, the cartridge 400 may comprise a mechanismto permit automatic decoupling of the cartridge base from the suturinginstrument 900 and/or the housing 10′. In the illustrated embodiment,once the suturing instrument 900 is withdrawn from the cartridge base420, the spring biased interlock 421′ is capable of automaticallyreturning from its second position 421B (shown in FIG. 2C) to itsoriginal position 421A (shown in FIG. 2A) to permit de-coupling of thebase 420 from the suturing instrument 900 and/or housing 10′ (chamber10).

Example 3

In an alternate embodiment of the present invention, as shown in FIGS.3A-3I, a cartridge 1000 is disclosed for loading suture onto a surgicalsuturing instrument, for example a suturing instrument 900 as discussedpreviously herein above with reference to FIG. 1E. The cartridge 1000carries suture therein and functions to align the suture with thesuturing instrument 900 upon insertion and axial advancement of thesuturing instrument 900 within the cartridge 1000, in order to allowtransfer of suture onto the surgical suturing instrument 900. In somesuch embodiments, the cartridge 1000 additionally functions to transferthe suture onto the suturing instrument 900.

In the specific example shown in FIGS. 3A and 3B, a cartridge 1000 isprovided that is functional to carry suture for loading onto a surgicalsuturing instrument 900. The cartridge comprises a housing 1010′ thatdefines a chamber for axially receiving the surgical suturing instrument900. Additionally, the chamber 1010 includes a recess or channel that isa part of the chamber 1010 that receives the suturing instrument 900. Assuch in some embodiments, as discussed herein the channel may bereferred to as a channel or a recess. In the particular examplediscussed herein the chamber 1010 defines a channel for receiving thesuturing instrument. The cartridge further comprises a base 1020 that isdetachably coupled to the housing 1010′ that defines a seat forreleasably holding the suture therein and enables alignment of thesuture with the suture passing member 930 of the suturing instrument900. The housing 1010′ additionally comprises a means to secure aportion of the suture thereto and is detachable from the base 1020 tofunction as a suture transferring component to transfer suture from thecartridge onto the suturing instrument 900. Thus, in some embodiments,as shown in FIG. 3B the base 1020 and the housing 1010′ compriseseparate components of the cartridge 1000 that are coupled to oneanother to assist in loading suture and may be detachable therefrom toassist in transferring suture. In other embodiments, the housing 1010′may be integrally formed with the base 1020. In some examples the base1020 may be formed from two halves 1020 a and 1020 b, and the housingsimilarly may also be formed from two halves 1010′a and 1010′b. Thehousing 1010′ and the base 1020 collectively provide alignment featuresto assist in alignment of the suture upon loading of the cartridge 1000onto the suturing instrument 900 to facilitate transfer of suture fromthe cartridge 1000 onto the suturing instrument 900 using the suturetransferring component. The detailed mechanism and operation of the base1020 and the housing 1010′ in aligning and transferring the suture aredescribed further herein below.

With reference now to FIG. 3C, in some embodiments the housing 1010′ ofthe cartridge defines a chamber 1010 that comprises a channel 1014 forreceiving the suturing instrument there-through. In some examples, thechannel 1014 comprises a proximal opening 1016 that narrows towards theinterior of the cartridge housing 1010′ as defined by a beveled interioredge 1016′. The beveled interior edge 1016′ functions as a lead in toguide the suturing instrument 900 into the channel 1014. The channel1014 extends longitudinally through the housing 1010′ and is incommunication with a recess 1025 that defines an instrument receivingrecess or locking recess] formed within the base 1020. In someembodiments the channel 1014 may be formed continuously with the recess1025 within the cartridge base 1020. The channel 1014 defines an openingthrough which the suturing instrument 900 may be advanced though thehousing 1010′ into the base 1020. The channel 1014 and the recess 1025each function as a restraint 25 to constrain or restrict the lateral andtransverse movement of the suturing instrument 900 within the cartridge1000 while allowing the suturing instrument 900 to be advanced linearlyor axially therein in sliding engagement to maintain the position of thesuturing instrument 900 along the longitudinal axis as it is advanced.As such the restraint 25 constraints or limits the movement of thesuturing instrument 900 in the transverse and lateral directions as wellalong a longitudinal path defined thereby. Thus the restraint 25facilitates alignment of the suturing instrument 900 with a portion ofthe suture 500 that is held within a seat 1022 defined by the base 1020.More specifically, the channel 1014 and the recess 1025 allow thesuturing instrument 900 to be advanced therein in sliding engagementtherein and additionally function to restrain the suturing instrument900 in a linear path as it is advanced along the cartridge 1000 to allowthe seat 1022 to be aligned with the suture receiving passage 932 of thesuture passing member.

Therefore, the cartridge 1000 comprises an alignment feature in the formof a restraint 25 that comprises an instrument receiving recess definedby channel 1014 and recess 1025, which allow the suturing instrument 900to be positioned within the base 1020 to allow the seat 1022 holding aportion of the suture to be aligned with the suture passing member 930of the suturing instrument 900.

Furthermore, in some embodiments as shown in FIGS. 3C, 3D and 3E, therecess 1025 within the base is formed from two grooves, an instrumentreceiving groove 1025 a defining an instrument receiving recess and asuture receiving groove 1025 b defining a suture receiving recess, asshown in FIG. 3F. The instrument and suture receiving grooves 1025 a and1025 b respectively are formed within the opposing halves 1020 a and1020 b of the base 1020 (also illustrated in FIG. 3B). With referenceagain to FIG. 3D, the instrument receiving groove 1025 a provides atrack which functions as a restraint 25 to allow the suturing instrument900 to be advanced therein, whereas suture groove 1025 b provides atrack to guide the portion of the suture held within the seat into thesuture passing member 930 of the suturing instrument 900 bymaintaining/routing the suture 500 therein such that it is adjacent andin line with the shaft or proximal portion 910 of the suturinginstrument 900 that is receivable within the instrument receiving groove1025 a as further illustrated in FIG. 3E. More specifically, the suturereceiving groove 1025 b allows the suture to be routed such that whenthe suturing instrument is received within the instrument receivingrecess 1025 b, the suture 500 is held adjacent the groove 928 within theshaft or the instrument proximal portion 910 as well groove 938 withinsuture passing member 930 such as needle 930′ (shown in FIG. 1E).Furthermore, the groove 1025 b provides room for routing the suturewithout excess tension being placed in the suture by providing a wideropening into a rocker recess 1027 as shown by FIGS. 3D and 4A. As suchthe groove 1025 b accommodates as it enters a rocker recess 1027 in botha final position 1041B as well as an initial position 1041A of a rocker1041 (Discussed further herein below). As such the suture receivinggroove 1025 b enables the suture 500 to be maintained out of the way ofthe advancing suturing instrument 900 during use of the cartridge 1000.Additionally recess groove 1025 b is in line with grooves 928, 938within the suturing instrument 900 to further facilitate transfer ofsuture from the seat 1022 within the base 1020 into the needle 930′. Inthe illustrated embodiment, both the instrument receiving groove and thesuture receiving groove exit into the rocker recess 1027.

With reference now to FIG. 3C in some embodiments of the presentinvention the cartridge 1000 additionally provides an alignment featurecomprising a moveable seat 1022. In some such embodiments, the cartridge1000 comprises a magazine 1021 that is defined by the base 1020 thatfunctions to align the suture with a portion of the surgical suturinginstrument 900 that is receivable within the cartridge 1000. Themagazine 1021 defines the seat 1022 for releasably holding or retaininga portion of the suture 500. More specifically, the seat 1022 isconfigured to hold an end portion 504 of the suture 500 as shown. Themagazine 1021 is moveable with respect to the cartridge 1000 and as suchdefines a moveable seat 1022 for aligning the suture end 504 heldtherein with a portion of the surgical suturing instrument 900 that isreceived within the cartridge 1000. More particularly, as shown in FIG.3C, the seat 1022 is moveable with respect to the base 1020.(Alternatively, in some embodiments the seat 1022 may be moveablerelative to the chamber 1010 defined by housing 1010′, for example inembodiments where the base 1020 may be formed integrally with thehousing 1010′ forming a unitary cartridge 1000).

In some embodiments of the present invention, particularly withreference to FIG. 3C, the seat 1022 is automatically moveable uponinsertion of the suturing instrument 900 within the cartridge 1000. Inthe particular example shown, the magazine 1021 comprises a rocker 1041that is rotatable about a pivot 1042, and the base 1020 defines a rockerrecess 1027 for enabling pivotal movement of the rocker 1041 therein. Inthe illustrated embodiment, the pivot 1042 is formed by laterallyextending pins 1043 of the rocker 1041 (also illustrated in 3G) that areheld within pivot support openings 1023 of the base 1020 and aremoveable freely therein. The rocker 1041 is moveable about the pivot1042 from its initial position 1041A (as shown in FIG. 3C) to its secondposition (as shown in FIG. 4C(i)) in order to align the seat 1022 andthe suture end 504 held therein with the path of an advancing suturinginstrument 900 that is inserted within the cartridge 1000.

In some embodiments, the rocker 1041 is held in its initial position1041A within the rocker recess 1027 through frictional engagement. Forexample the rocker 1041 may be kept in its initial position 1041A by anengagement feature such as a raised tab or detent [not shown] that isformed within the base 1020 and may extend or juts into the rockerrecess 1027. The tab may be engageable with a portion of the rocker 1041to maintain the rocker in its initial position 1041A during shipment andprior to use. In other embodiments the rocker 1041 may be held in itsinitial position 1041A through frictional engagement via a spring basedmechanism. The frictional force may be sufficient to keep the rocker1041 in its initial position 1041A when the cartridge is empty, butmaybe overcome upon contact with the suturing instrument 900. Thus therocker 1041 may be released from engagement with the base 1020 uponadvancement of the suturing instrument 900 within the cartridge 1000allowing the rocker 1041 to move into its second position 1041B to alignthe portion of the suture held therein with a portion of the suturinginstrument 900. In its second position 1041B, the rocker 1041 moves intoa cavity defined by the rocker recess 1027. More specifically, asdefined herein the rocker 1041 is moveable into a rocker cavity 1027′ ofthe rocker recess 1027 to align the seat 1022 with the suturinginstrument 900. The rocker cavity 1027′ is defined as a portion of therocker recess 1027 that corresponds to a tissue receiving gap 942 of thesuturing instrument 900, upon loading of the cartridge 1000 onto thesuturing instrument 900 [FIG. 3C].

In some embodiments, the cartridge may comprise additional features thatassist in aligning the seat 1022 with a portion of the suturinginstrument 900 as the suture passing member 930 held within the shaft orinstrument proximal portion or shaft 910. In one such example, referringagain to FIG. 3C, the rocker 1041 additionally defines an instrumentreceiving or locking recess defined by a groove 1044 that is designedfor receiving the suturing instrument 900 as it is advanced distally.The groove 1044 functions as a restrain to position the suturinginstrument 900 in a desired position relative to the seat 1022 to assistin aligning the seat 1022 with a suture passing instrument 900. Thegroove 1044 enables the rocker 1041 to pivot down into its secondposition 1041B while allowing the suturing instrument 900 to be advancedinto the cartridge 1000 to permit loading the suture into the suturinginstrument 900. [The operation of the groove 1044 is discussed furtherherein below with reference to FIGS. 4A-4D that illustrate the operationof the device]. As further shown in FIGS. 3H and 3I, the groove 1044comprises a groove proximal portion 1046 for receiving the instrumentproximal portion or shaft 910 of the suturing instrument 900, andadditionally comprises a groove distal portion 1048 for receiving theinstrument distal portion or tip 920.

Additionally, the rocker 1041 comprises a median 1047 that is defined bythe groove 1044. The groove proximal and distal portions 1048, 1048 areseparated by the median 1047 functions to hold or define the seat 1022to enable the seat to be brought down into the tissue receiving gap 942.The median 1047 functions as an alignment feature by holding andaligning the seat 1022 with the suture passing member such as needle930′ of the suturing instrument 900. As such median 1047 functions toholding the seat to enable the seat 1022 to be brought down into thecavity 1027′corresponding to the tissue receiving gap upon reception tothe suturing instrument within the cartridge.

Still furthermore the groove 1044 defines an additional alignmentfeature in the form of an interior bevel face 1043 that is defined bythe groove distal portion 1048 of the rocker 1041, along a distal endthereof. The bevel 1043 enables the distal portion 920 of the suturinginstrument to pivot the rocker 1041 from its initial position 1041A intoits aligned position or second position 1041B to enable alignment of theseat 1022 and the suture held therein with the suture passing member 930of the suturing instrument.

In some embodiments, the rocker 1041 additionally defines anotheralignment feature in the form of a slot 1049 (as shown in FIG. 3J) and3L within the groove 1044 to assist in alignment and transfer of thesuture end 504 into the suture passing member 930. The slot 1049comprises a slit or channel 1049 a that is formed within a wall 1044′ ofthe rocker 1044 and extends transversally along the base of the wall1044′ to route the suture there-through upon exiting the seat 1022. Theslit or channel 1049 a functions to retain the suture 500 therein as itexits the seat 1022 within the rocker 1041 to aid in routing the suture500 within the suture receiving groove 1025 b (FIG. 3D) of the base 1020and to align the suture with the suture receiving slot 928 in the shaft.The slit or channel 1049 exists into a cut-out portion defined withinthe exterior wall of the rocker 1041. The cutout defines a side slot1049 b defining a space enabling the suture 500 to be routedthere-through to be guided into the suture receiving groove 1025 b ofthe base 1020. The slit or groove 1049 a is in communication with therocker side slot 1049 b to hold the suture to the side within the suturereceiving groove 1025 b of the base. This allows the suture to be heldto the side of the suturing instrument 900 during advancement of thesuturing instrument within the cartridge base 1020.

In one specific example, as shown in FIGS. 3J and 3K, the seat 1022 isdefined by a projection 1030 that is housed within the magazine 1021,specifically within the rocker 1044. In one specific embodiment, themedian 1047 comprises an axially extending channel or opening thereinfor receiving and retaining a projection 1030 that defines the seat1022. In some embodiments, the projection may be press-fit within thechannel or opening. In other embodiments it may be coupled to the medianusing an adhesive. In other embodiments the projection 1030 defining theseat 1022 may be formed in one piece as part of the rocker. Theprojection 1030 defines a hollow interior forming a seat channel 1024and the suture end 504 is press-fit within the seat channel 1024 to beheld therein. As such the projection 1030 forms an alignment feature tofurther aid in aligning the seat 1022 with the suture receiving passage932 of the suture passing member 930 such as the needle 930′ within theshaft 910. As shown in FIGS. 3M and 4D, the projection 1030 extends intothe instrument receiving recess defined by the groove 1044. Morespecifically, the projection 1030 is capable of abutting against/matingwith the suture passing member 930 (such as needle 930′) when broughtinto engagement therewith. In one specific example, the projection 1030defines a bevel face 1034 for engaging with a bevel face 934 of theneedle 930′ for docking the needle 930′ to align the seat 1022 with theneedle 930′ with to permit transfer of the suture end 504 from the seat1022 into a suture receiving passage 932 of the needle 930′. In onespecific example, the projection 1030 is receivable into the instrumentproximal portion or shaft 910 to facilitate alignment of the seat 1022with the needle 930′.

In some such embodiments, as shown in FIG. 3K, the rocker 1041 comprisesadditional alignment features to assist in alignment of the seat 1022.In one such example the projection 1030 comprises interference featuresin the form of raised bumps 1045 a on the exterior of the projection1030 that are configured to frictionally engage the interior of theinstrument proximal portion or shaft 910 with the needle 930′ as theprojection 1030 is received within the shaft 910. In additionalembodiments, the rocker 1041 also, as shown in FIGS. 3K and 3M, thecartridge 1000 defines a suture groove or slot to allow the suture toexit the seat 1022. In some such embodiments, the rocker 1041 defines asuture slot that is in communication with the seat 1022 for allowing thesuture to exit the seat 1022. In the specific example shown thecomprises additional raised bumps 1045 b along the interior of theproximal groove portion 1046 for frictionally engaging the exterior ofthe instrument proximal portion or shaft 910 once it is received withinthe proximal groove portion 1046 in order to align the seat 1022 withthe needle 930′. This may be referred to as the needle-in configurationof cartridge 1000 as the needle 930′ remains inside the shaft 910 duringloading of the suturing instrument 900.

In some embodiments projection 1030 defines a suture slot 1038 thereinallowing the suture 500 to exit therefrom to enable alignment of thesuture end 504 with the suture receiving passage 932 within the needle930′. More specifically, the suture slot 1038 enables the suture to beto be routed through it upon exiting the seat 1022, such that suture isaligned with the needle slot 928 and shaft slot 938. This facilitatestransfer of the suture end into the suture receiving passage 932 of theneedle 930 using a suture transferring component of the cartridge 1000.Once the suture exits the suture slot 1038, it is routed though the slot1049 of the rocker 1041 to enable suture be held to the side of therocker such that it is off to the side of the path of the suturinginstrument 900 as it is advanced into the cartridge 1000.

In an alternate embodiment of the present invention, as shown in FIGS.3L and 3N, the magazine, for example the rocker 1041, comprises analignment recess 1030′ that is located adjacent the seat, for holdingthe suture therein. In some such embodiments, the rocker 1041 defines anopening/space or such as a seat recess or seat channel that forms theseat 1022′ for holding the suture end 504 in frictional engagementtherein. The alignment recess 1030′ is positioned adjacent the seat1022′ and is in line with the suture passing member 930. The alignmentrecess 1030′ and is configured for receiving the suture passing member930 (such as needle 930′) therein, to allow suture end 504 to betransferred from the seat 1022′ to the suture receiving passage 932 ofthe suture passing member 930. The present configuration of thecartridge 1000 may be referred to as the needle-out configuration as theneedle 930′ is maintained in a partially extended position duringloading of the cartridge 1000 onto the suturing instrument 900, as shownin FIG. 3N. In other words a distal portion of the needle 930 extendsdistally outside the shaft 910 of the suturing instrument at the time ofloading the cartridge 1000 onto the suturing instrument. For example,the suture passing member 930 such as the needle 930′ can be held in apartially extended position to allow the needle 930′ to be receivingwithin the alignment recess 1030′ for loading of suture therein. In someembodiments, a needle lock is provided that is mounted along theinstrument proximal portion or shaft 910 of the suturing instrument 900and is engageable with an aperture 935 within the needle 930′ in itslocking position to maintain the needle 930′ in the partially extendedposition during loading of the cartridge 1000 onto the suturinginstrument 900. The needle lock may be disengaged thereafter to allowthe needle 930′ to be retracted to its nominal position prior to use ofthe suturing instrument 900.

In one specific example, as shown in FIG. 3 o , the needle lockcomprises a cam lock 937 comprising a cam 939 within a cam housing 939′.In its locked position 937A as shown, the cam is engaged with theaperture 935 of the needle 930′ preventing the needle 930′ fromretracting into the instrument proximal portion or shaft 910. As suchthe cam 939 allows the needle 930′ to remain in its partially extendedposition to allow the needle 930′ to be received within the alignmentrecess 1030′ of the cartridge 1000 facilitating alignment and transferof suture end form the seat 1022′ into the needle 930′. The cam 939 maythen be disengaged from the needle aperture 935 thereafter moving thecam lock 937 into its unlocked position which the needle 930′ to retractback into the shaft or instrument proximal portion 910. In someexamples, a component of the cartridge 1000, for example a component ofthe cartridge housing 1010′ may moveable proximally along the instrumentproximal portion of shaft 910 to disengage the cam lock moving it intoits unlocked position to allow the needle to move into itsunactuated/nominal position.

In some such embodiments, as shown in FIG. 3L, the rocker 1041 comprisesadditional alignment features to assist in alignment of the seat 1022′.In one such example, the alignment recess 1030′ adjacent the seat 1022′comprises interference features for frictionally engaging an exterior ofthe needle 930′ of the suturing instrument 900 upon advancement of theneedle 930′ into the alignment recess 1030′. More specifically, thecartridge 1000 comprises interference features in the form of raisedbumps 1045 a on the inner surface of the wall defining the alignmentrecess 1030′. The raised bumps 1045 a extend proximally along the innersurface of the wall of the alignment recess 1030′ and are configured tofrictionally engage the exterior of the needle 930′ as the needle 930′is received within the alignment recess 1030′. As outlined previouslyherein above for the embodiment illustrated in FIG. 3 k , the rocker1041 shown in FIG. 3L, also comprises additional raised bumps 1045 balong the interior of the proximal groove portion 1046 for frictionallyengaging the exterior of the instrument proximal portion or shaft 910once it is received within the proximal groove portion 1046 in order toalign the seat 1022 with the needle 930′. This may be referred to as theneedle-out configuration of the cartridge 1000 as the needle 930′remains partially extended outside the distal end of the shaft 910,during loading of the cartridge 1000 onto the suturing instrument 900.

In some embodiments, as shown in FIG. 3L, the cartridge 1000 defines asuture groove or slot to allow the suture to exit the seat 1022. In somesuch embodiments, the rocker 1041 defines a suture slot that is incommunication with the seat 1022 for allowing the suture to exit theseat 1022. In the specific example shown in FIG. 3L, the alignmentrecess 1030′ defines a suture slot 1038′ therein allowing the suture 500to exit therefrom to enable alignment of the suture end 504 with thesuture receiving passage 932 within the needle 930′. More specifically,the suture slot 1038′ enables the suture to be to be routed through itupon exiting the seat 1022, such that suture is aligned with the needleslot 928 and shaft slot 938. This facilitates transfer of the suture endinto the suture receiving passage 932 of the needle 930 using a suturetransferring component of the cartridge 1000. Once the suture exits thesuture slot 1038′, it is routed though the slot 1049 of the rocker 1041to enable suture be held to the side of the rocker such that it is offto the side of the path of the suturing instrument 900 as it is advancedinto the cartridge 1000.

In some embodiments of the present invention, the rocker 1041additionally comprises interference tabs 1048 x (as shown in 9M) forengagement with the suturing instrument 900 which allow the rocker 1041to over-rotate to ensure alignment of the rocker 1041 with theinstrument proximal portion or shaft 910 of the suturing instrument 900to allow advancement of the rocker 1041 along the shaft 910. In otherwords the interference tabs 1048 x may allow the rocker 1041 to rotatesufficiently to enable the seat 1022 to be positioned adjacent thesuturing instrument 900 by ensuring that the shaft 910 is receivedwithin the rocker groove proximal portion 1046. For example where theseat 1022 is defined by the projection 1030, the interference tabs allowthe rocker 1041 to rotate sufficiently to enable the projection 1030 tobe received within the instrument shaft 910. Whereas, where the seat1022 is positioned adjacent an alignment recess (as discussed earlierwith reference to FIG. 3N, the interference tabs allow the rocker 1041to rotate sufficiently such that the alignment recess and the seat 1022adjacent to it are both aligned with the needle 930′.

As outlined previously herein, with reference to FIG. 3A-3C someembodiments of the present invention define base 1020 that is detachablycoupled to the housing 1010′ enabling the base 1020 and the housing1010′ to operate as a single unit upon loading of the cartridge 1000onto the suturing instrument 900 where both the base 1020 and thehousing 1010′ provide features to assist in alignment of a portion ofthe suture 500 such as a suture end 504 with the suture passing member930. In some such embodiments, the housing 1010′ additionally comprisesa means to frictionally engage a portion of the suture and is detachablefrom the base 1020 after alignment of the suture portion with the suturepassing member 930 to transfer the suture portion into the suturepassing member. In one such example as described further herein belowthe means to frictionally engage a portion of the suture comprises asuture lock.

As such, the cartridge housing 1010′ defines a suture transferringcomponent 1011 to transfer of the suture end into the suture passingmember 930. In one embodiment as shown and described herein the suturetransferring component 1011 is operable to pull the portion of thesuture that is held in frictional engagement in order to transfer thesuture portion such as suture end 504 held within the seat 1022, ontothe suturing instrument 900. As such the cartridge 1000 comprises asuture transferring component 1011 that forms or defines a pullmechanism as described further in the method outlined herein below. Thepull mechanism is defined as the mechanism of the cartridge that enablesa pulling force to be exerted or applied to the suture portion such asthe suture end to transfer the suture portion from the seat into thesuturing instrument. In some embodiments the housing 1010′ mayadditionally comprise suture loops that form a partially pre-tied knotthat are mounted about the housing 1010′. Additionally in someembodiments the housing 1010′ may provide a means to house excesssuture. In one example, the excess suture may be provided on spools thatare carried by housing 1010′.

In some embodiments of the present invention as shown in FIGS. 3B, 3Cand 3G, the cartridge base 1020 is detachably coupled to the cartridgehousing 1010′ via an interlock. In the specific example shown, thecartridge housing 1010′ defining the suture transferring component 1011,comprises an interlock 1050. The interlock 1050 secures the base 1020 tothe housing 1010′ (and thus the suture transferring component) allowingthe cartridge 1000 to operate a single functional unit upon loading ofthe cartridge 1000 onto the suturing instrument 900, until the seat 1022is aligned with the suturing passing member 930. The interlock 1050 maythen be disengaged to allow the housing 1010′ that defines the suturetransferring component 1011 to translate independently along thesuturing instrument 900 to transfer the suture end 504 from the seat1022 into the suture passing member 930 of the suturing instrument 900.FIGS. 5A-5C, illustrate the interlock 1050 in its initial lockedposition 1050A, with the interlock arms 1056 of the interclock 1050being axially aligned with the locking arms 1026 of the base. Theinterlock arms 1056 prevent movement of the housing 1010′ with respectto the base 1020 to form a cartridge unit 1000 by blocking longitudinalmovement of the locking arms 1026 of the base 1020 (and as such blockthe longitudinal movement of the base 1020). The function of theinterlock 1050 is described further herein below with respect to FIGS.5A-6B. The interlock 1050 is moveable into its unlocked position 1050Bto allow the housing 1010′ to be disengaged from the base 1020. In someembodiments, the interlock 1050 comprises a manual interlock that ismoveable into the unlocked position 1050B to manually disengage thehousing 1010′ (and thus the suture transferring component 1011 definedthereby) from the base 1020 upon alignment of the seat 1022 with thesuture passing member 930.

Still furthermore, suture transferring component defined by the housing1010′ comprises a means to hold a portion of the suture 500 infrictional engagement with the housing 1010′ to allow the housing 1010′to move the suture 500 therewith to enable the housing 1010′ to transferthe suture end 504 held within the seat 1022 of the base to the suturepassing member 930. In the embodiment shown in FIGS. 3C and 3G, aportion of the suture is held in frictional engagement with a suturelock 1060 to secure the suture 500 thereto to enable the housing to pullthe suture end 504 by applying tension to the suture (for example asegment of suture held in frictional engagement within the housing, forexample via a suture lock) from the seat 1022 into the suture passingmember 930.

More specifically, in the embodiment shown, the suture 500 is heldwithin the cartridge 1000 such that the suture 500 is routed from thesuture end 504 within the seat 1022 upon exiting the seat slot 1038 suchthat it enters the slot 1049 of the rocker to be routed there-through.More specifically, in some examples the suture passed through andpinched within the slit or channel 1049 such that it is held therein ina force fit engagement. The suture 500 then enters the side slot 1049 bon the exterior face of the rocker 1041 [FIGS. 3J and 3L]. The suture500 exits the rocker 1041 into the rocker recess 1027 and is routedthrough the recess groove 1025 b within the base 1020 which allows thesuture 500 to be maintained within recess groove 1025 b adjacent and outof the way of the path of the suturing instrument 900 to be insertedthrough the recess groove 1025 a [FIG. 3D]. The suture is then routedthrough an opening 1051 within the interlock and guided into a suturechannel 1061 to engage with the suture lock 1060 In one particularembodiment, as shown in FIGS. 7A-7E the suture lock 1060 comprisesprojections or teeth 1064 defining contours or ridges and valleys thatare configured to engage corresponding features in the form orprojections or teeth 1064 within a suture lock engaging component 1062of the housing 1010′. The suture 500 is routed through the suture lockengaging component 1062 of the housing 1010′ and the suture lock 1060 ispress fit to engage with the suture lock engaging component 1062pressing the suture between the two, and as such coupling the suture tothe housing 1010′. FIGS. 7B and 7E show the lock in its initial lockedconfiguration 1060A. The lock 1060 remains in its locked configurationuntil the suture portion such as the end of the suture has been loadedinto the suturing instrument 900. It is moveable thereafter into itssecond of unlocked configuration as shown in FIGS. 7C and 7D andadditionally in FIG. 7F to allow the suture 500 to be disengaged fromthe housing 1010′.

In some embodiments, as described herein above in example 3, themovement of the suturing instrument 900 may be a relative movement withrespect to the cartridge 1000. In other words the user may move thecartridge 1000 axially over the suturing instrument 900 in a proximaldirection while the suturing instrument is held by the user in order tocreate a relative advancement of the suturing instrument 900 withrespect to the cartridge 1000 in order to load the suture onto thesuturing instrument 900. This may be refer to as loading of suture usingpumping action. As such, the mechanism of loading of the suture mayremain as described above but the movement may be created either by theproximal movement of the cartridge over the suturing instrument or thedistal movement of the suturing instrument within the cartridge.

In some embodiments of the present invention as described herein, thecartridge is configured to align and transfer the suture upon a singlelinear motion of the cartridge with respect to the suturing instrument.In some such embodiments, the interlock 1050 may be automaticallydisengaged upon alignment of the suture end within the seat with thesuture passing member to enable automatic transfer of the suture end 504into the suture passing member as the housing 1010′ is continued to bepulled proximally. Additionally the suture lock 1060 may beautomatically disengaged thereafter upon transfer of the suture end fromthe seat 1022 into the suture passing member 930, which would allow thesuturing instrument to be able to pass the suture in order to suturetherewith. In some such embodiments, the cartridge is loaded onto thesuturing instrument 900 with a single linear movement. In some suchembodiments a single pumping action is used involving a single linearrelative movement of the cartridge onto the suturing instrument andremoval of the base 1020 [for example via a linear movement in theopposing direction to the loading direction] thereafter leaving thehousing coupled to the suturing instrument for example to mount apre-tied knot held therein onto the suturing instrument.

Example 4

In an alternate embodiment of the present invention, as shown in FIGS.8A-8C, a cartridge 2000 is disclosed for loading suture onto a surgicalsuturing instrument, for example a suturing instrument 900 as discussedpreviously herein above with reference to FIGS. 1D and 1E. Similar toembodiments described previously herein above, the cartridge 2000carries suture therein and allows suture to be loaded onto a surgicalsuturing instrument 900 for example, at the point of use. The cartridge2000 functions to align the suture with the suturing instrument 900 uponinsertion and relative axial advancement of the suturing instrument 900within the cartridge 2000, and additionally functions to transfer of thesuture onto the surgical suturing instrument 900. In some suchembodiments, either the suturing instrument 900 may be advanced distallyinto the cartridge 2000 or the cartridge 2000 may be pulled proximallyover the suturing instrument. As described herein either of thesetechniques may be utilized to provide the functionally described hereinfor creating relative axial movement between the cartridge 2000 and thesuturing instrument 900 for loading the suture onto the suturinginstrument 900. This is also applicable to embodiments described hereinabove in example 3. In some such embodiments, the cartridge 2000additionally provides a pre-tied knot therein and enables the pre-tiedknot to be loaded onto the suturing instrument 900. In some embodiments,the pre-tied knot may comprise loops that substantially form a pre-tiedknot. In other words a pre-tied knot may comprise a partially pre-tiedknot. In some such embodiments, the partially pre-tied knot isconfigured to be deployed from the suturing instrument after suturing toform a knot to secure the suture.

With reference now to FIGS. 8B and 8C, the cartridge comprises a housing2010′ that defines a chamber 2010 for axially receiving the surgicalsuturing instrument 900. The cartridge 2000 further comprises a base2020 that is detachably coupled to the housing 2010′, the base 2020defining a seat 2022 for releasably holding the suture therein [As shownin FIG. 8E(ii)]. The base 2020 enables alignment of the suture heldtherein with the suture passing member 930 of the suturing instrument900. The housing 2010′ additionally comprises a suture transferringcomponent to transfer suture from the base 2020 onto the surgicalsuturing instrument 900. Thus, in some embodiments, as shown in FIG. 8Bthe base 2020 and the housing 2010′ comprise separate components of thecartridge 2000 that are coupled to one another to assist in loadingsuture and may be detachable therefrom to assist in transferring suture.The housing 2010′ additionally comprises a chamber 2010 therein and ameans for securing or mounting a pre-tied knot 502 about the chamber2010, to enable the pre-tied knot to be mounted onto the suturinginstrument 900. The housing 2010′ and the base 2020 collectively providealignment features to assist in alignment of the suture upon loading ofthe cartridge 2000 onto the suturing instrument 900 to facilitatetransfer of suture from the cartridge 1000 onto the suturing instrument900 using the suture transferring component. In some embodiments thehousing 2010′ comprises a knot slider 2030 that defines the chamber2010, the knot slider 2030 includes suture loops coupled thereto, thesuture loops are configured to form a knot upon deployment thereof fromthe knot slider 2030, wherein the suturing instrument 900 is receivablewithin the chamber 2010 for mounting the suture loops onto the suturinginstrument.

In some such embodiments, a suturing system is provided that comprises asuturing instrument 900 comprising a suture passing member 930; and acartridge (such as cartridge 2000) for releasably holding an end of asuture and defining a chamber 2010 for coupling a partially pre-tiedknot thereabout, the chamber 2010 is configured to receive the suturinginstrument 900 therethrough. The cartridge 2000 is configured totransfer the suture end 504 into to the suture passing member 930 and totransfer the partially pre-tied knot (for example 502) onto the suturinginstrument. In some such examples the suture passing member 930 isconfigured to pass the suture end 504 from a proximal side of a tissueto a distal side of the tissue in a first actuation of the suturepassing member.

In an additional embodiment, a cartridge (such as cartridge 2000) isprovided for loading suture onto a suturing instrument 900 to enable thesuturing instrument to form a pre-tied knot, the cartridge comprises: achamber 2010 for receiving a suturing instrument 900, the chamber 2010supporting loops of suture coupled thereto (such as loop 502 shown inFIG. 8B) for transferring onto the suturing instrument 900 uponadvancement of the suturing instrument into the chamber 2010, the loops502′ of suture being configured to form a pre-tied knot upon deploymentfrom the suturing instrument; and a seat 1022 for releasably holding aportion of the suture to enable transfer of the suture portion 504 ontothe suturing instrument, the suture portion comprising an end of thesuture configured to define a post of the pre-tied knot upon deploymentof the loops from the suturing instrument.

In one particular embodiment, the cartridge housing 2010′ is detachablycoupled to the base 2020 and defines a chamber 2010 for receiving thesurgical suturing instrument 900 there-through. In some suchembodiments, the chamber 2010 additionally comprises a means for storinga pre-tied knot about the chamber. In some embodiments, the housing2010′ additionally comprises a knot slider 2030 defining the chamber2010 having a pre-tied knot mounted thereon wherein the surgicalsuturing instrument is receivable within the chamber 2010 to mount thepre-tied knot onto the surgical suturing instrument 900. In oneparticular example, the cartridge housing 2010′ comprises an outerhousing sleeve 2011′ that defines a hollow interior for holding the knotslider 2030 therein. The knot slider 2030 is detachably coupled to thehousing sleeve 2011′ and forms a part of the housing 2010′. In aparticular example as shown in FIG. 8B, the knot slider 2030 isdetachably coupled to the housing 2010′ via the base 2020 for holding apre-tied knot about the chamber 2010.

Additionally, the chamber 2010 includes a recess or channel 2014 that isa part of the chamber that receives the suturing instrument. In theparticular example discussed herein the chamber 2010 defines a channel2014 as shown in FIG. 8D which illustrates a rear view of the knotslider 2030 to allow a portion the suturing instrument 900 to bereceived there-through As such the channel 2014 defines an instrumentreceiving recess for receiving the suturing instrument 900 thatadditionally functions as a restraint for maintaining the position ofthe suturing instrument 900 as it is advanced through the cartridge2000. Similar to Example 3 described previously herein above, in someexamples, the channel 2014 comprises a proximal opening 2016 thatnarrows towards the interior of the knot slider 2030 as defined by abeveled interior edge 2016′. The beveled interior edge 2016′ functionsas a lead in to guide the suturing instrument 900 into the channel 2014.

The channel 2014 extends longitudinally through the knot slider 2030 ofthe housing 2010′ and is in communication with a base recess 2025 withinthe base 2020. As shown in FIGS. 8A-8C, the base 2020 is detachablycoupled to the housing 2010′. More specifically, the base 2020 is heldwithin the housing sleeve 2011′. In some examples the channel 2014 maybe formed continuously with the base recess 2025 within the cartridgebase 2020. One example of this discussed further herein below. Thechannel 1014 and the base recess 1025 both function as a restraint 25(FIG. 8E (i)), to constrain or restrict the lateral and transversemovement of the suturing instrument 900 within the cartridge 2000 whileallowing the suturing instrument 900 to be advanced linearly or axiallytherein in sliding engagement to maintain the position of the suturinginstrument 900 along the longitudinal axis as it is advanced. As suchthe restraint 25 constraints or limits the movement of the suturinginstrument 900 in the transverse and lateral directions as well along alongitudinal path defined thereby. Thus the restraint 25 facilitatesalignment of the suturing instrument 900 with a portion of the suture500 that is held within a seat 1022 defined by the base 2020. Morespecifically, the channel 1014 and the recess 1025 allow the suturinginstrument 900 to be advanced therein in sliding engagement therein andadditionally function to restrain the suturing instrument 900 in alinear path as it is advanced along the cartridge 2000 to allow the seat1022 to be aligned with the suture receiving passage 932 of the suturepassing member 930.

Furthermore, similar to embodiments discussed previously with respect toExample 3 herein above, the recess 2025 within the base is formed fromtwo grooves, an instrument receiving groove 2025 a defining aninstrument receiving recess as shown in FIG. 8E(i) and FIG. 8E(ii) and asuture receiving groove 1025 b defining a suture receiving recess, asshown in FIG. 8F(i) and FIG. 8F(ii). The instrument and suture receivinggrooves 2025 a and 2025 b respectively are formed within the opposinghalves 2020 a and 2020 b of the base 2020 (as illustrated in FIGS.8E(i)-FIG. 8F(ii)).

With reference again to FIGS. 8E(i),(ii) the instrument receiving groove2025 a defines an instrument receiving recess by providing a track whichfunctions as a restraint 25 to allow the suturing instrument 900 to beadvanced therein, whereas suture groove 2025 b (FIG. 8F(i)) provides atrack to guide the portion of the suture held within the seat into thesuture passing member 930 of the suturing instrument 900 bymaintaining/routing the suture 500 therein such that it is adjacent andin line with the shaft or proximal portion 910 of the suturinginstrument 900 that is receivable within the instrument receiving groove2025 a as further illustrated in FIGS. 8F(ii) and 8G. More specifically,the suture receiving groove 2025 b allows the suture to be routed suchthat when the suturing instrument is received within the instrumentreceiving recess 2025 b, the suture 500 is held adjacent the groove 928within the shaft or the instrument proximal portion 910 as well groove938 within suture passing member 930 such as needle 930′ (shown in FIG.1E). Furthermore, the groove 2025 b provides room for routing the suturewithout excess tension being placed in the suture by providing a wideropening into a rocker recess 2027 as shown by FIG. 8F(ii). As such thegroove 2025 b accommodates the suture as it enters a rocker recess 2027in both a final position 1041B as well as an initial position 1041A of arocker 1041 (Discussed further herein below). As such the suturereceiving groove 2025 b enables the suture 500 to be maintained out ofthe way of the advancing suturing instrument 900 during use of thecartridge 2000. Additionally recess groove 2025 b is in line withgrooves 928, 938 within the suturing instrument 900 to furtherfacilitate transfer of suture from a seat 2022 for example within therocker 1041 within the base 2020 into the needle 930′. In theillustrated embodiment, both the instrument receiving groove and thesuture receiving groove exit into the rocker recess 2027.

In some embodiments as provided herein the cartridge 2000 additionallyprovides a pre-tied knot and a means to load the pre-tied knot onto thesuturing instrument 900. In some such embodiments, the cartridge definesa chamber 2010 and a means to mount or retain a pre-tied knot about thechamber 2010. In one such example as discussed herein a knot slider 2030is provided with reference to FIG. 8C that enables a pre-tied knot to bemounted thereon so that it is held about and surrounds or circumscribesthe chamber 2010. This enables the suturing instrument 900 to bereceived through a channel 2014 within the chamber 2010 such that ispasses through the pre-tied knot to allow the pre-tied knot to bemounted thereon. In one specific example the knot slider forms a mount2012″ for holding the pre-tied knot 502 about the chamber 2010, as shownin FIGS. 8B and 8C. The pre-tied knot 502 may be of the type aspreviously illustrated herein in FIG. 1A. In some embodiments, the knotslider 2030 forms an instrument mounted component of the cartridge 2000.

Additionally some embodiments of the present invention provide a meansto hold the knot slider 2030 within the cartridge 2000 to permit theknot slider 2030 to be held therein until a suturing instrument 900 isinserted within the cartridge 2000 to enable the knot slider 2030 to bedetached from the rest of the cartridge 2000 to be coupled to thesuturing instrument 900 thereafter. In some such embodiments, the knotslider 2030 is held within a knot slider recess 2018 (FIG. 8B and FIG.8C) within the outer sleeve 2011′ and is detachably coupled thereto viathe base 2020. In one particular example, the knot slider 2030 isdetachably coupled to the base 2020 via a knot slider release interlock2033 that for example comprises a snap fit arrangement as shown in FIG.8H(i) As additionally illustrated in FIGS. 8E(i), 8F(i), the basecomprises snap arms 2042 that are receivable within and engageable withgrooves formed within the knot slider 2030 that may be referred to assnap grooves 2032 to couple knot slider 2030 therein, forming the knotslider release interlock 2033. In order to facilitate coupling betweenthe knot slider 2030 and the base 2020, the base 2020 additionallycomprises a knot slider s 2040 therein that is configured for receivinga portion of the knot slider 2030 therein.

In the illustrated embodiment, the knot slider 2030 is detachable fromthe base to enable loading of the knot slider 2030 and thus the pre-tiedknot 502 onto the suturing instrument 900 upon disengagement of the knotslider release interlock 2033. In one specific embodiment, the knotslider 2030 is detachable from the base 2020 upon relative movement ofbase 2020 with respect to the housing 2010′. In one such example, theknot slider 2030 is moveable distally along the knot slider recess 2018within the housing sleeve 2011′ upon distal movement of the base 2020within the housing sleeve 2011′. However, the wall 2019′ of the housingsleeve 1011′ adjacent the tapered inner wall 2019 [FIG. 8B] of the knotslider recess 2018 functions as a stop to prevent further distalmovement of the knot slider 2030 to disengage snap arms 2042 of the base2020 from the snap grooves of the knot slider 2030, and as suchdisengages the knot slider release interlock 2033.

In some embodiments of the present invention, the cartridge 2000 definesa moveable seat 1022 as previously described herein above with referenceto FIG. 3C, the seat 1022 is automatically moveable upon insertion ofthe suturing instrument 900 within the cartridge 2000. In the particularexample shown, the cartridge 2000 comprises a magazine 1021 comprising arocker 1041 that is rotatable about a pivot, and the base 2020 defines arocker recess 2027 for enabling pivotal movement of the rocker 1041therein Similar to the embodiments illustrated in FIGS. 3C and 4C(i),the rocker 1041 is moveable about the pivot 1042 from its initialposition 1041A (as shown in FIG. 9A(i),(ii)) to its second position1041B (as shown in FIG. 9B(i),(ii)) in order to align the seat 1022 andthe suture end 504 held therein with the path of an advancing suturinginstrument 900 that is inserted within the cartridge 2000. As outlinedpreviously in example 3, as defined herein the rocker 1041 is moveablewithin the rocker recess 2027. The rocker 1041 is moveable from itsfirst position 1041A into a rocker cavity 2027′ its second position1041B, as shown in FIG. 9B(ii). The rocker cavity 2027′ is defined as aportion of the rocker recess 2027 that corresponds to the tissuereceiving gap 942 of the suturing instrument 900 once suturinginstrument 900 is positioned within the base 2020 of the cartridge 2000upon loading of the cartridge 2000 onto the suturing instrument.

In some embodiments, the rocker 1041 is held in its initial position1041A within the rocker recess 2027 through frictional engagement. Forexample the rocker 1041 may be kept in its initial position 1041A by anengagement feature such as a raised tab or detent 2029 as shown in FIGS.8C and 8F(i), that frictionally engages the rocker 1041. The tab ordetent 2029 is formed within the base 2020 and may extend or jut intothe rocker recess 2027. The tab 2029 is engageable with a portion of therocker 1041 (for example a nose portion 1081) of the rocker 1041 asshown in FIG. 8F(ii), to maintain the rocker in its initial position1041A during shipment and prior to use.

In some embodiments, for example as provided in Example 4, the cartridge2000 may comprise additional features that assist in aligning the seat1022 with a portion of the suturing instrument 900 as the suture passingmember 930 held within the shaft or instrument proximal portion or shaft910. In one such example, with reference earlier to FIG. 3C, the rocker1041 additionally defines an instrument receiving or locking recessdefined by a groove 1044 that is designed for receiving the suturinginstrument 900 as it is advanced distally. The groove 1044 functions asa restrain to position the suturing instrument 900 in a desired positionrelative to the seat 1022 to assist in aligning the seat 1022 with asuture passing instrument 900. As shown and discussed previously withreference to FIGS. 3H and 3I, the groove 1044 comprises a grooveproximal portion 1046 for receiving the instrument proximal portion orshaft 910 of the suturing instrument 900, and additionally comprises agroove distal portion 1048 for receiving the instrument distal portionor tip 920.

As discussed earlier with respect to Example 3, the rocker 1041 ofExample 4 additionally comprises a median 1047 (FIG. 9A(i) that isdefined by the groove 1044 that functions as an alignment feature byholding and aligning the seat 1022 with the suture passing member suchas needle 930′ of the suturing instrument 900.

Still furthermore, the groove 1044 defines an additional alignmentfeature in the form of an interior bevel face 1043 (FIG. 9A (i)) withinthe distal groove portion 1048 to enables the distal portion 920 of thesuturing instrument to pivot the rocker 1041 from its initial position1041A into its aligned position or second position 1041B to enablealignment of the seat 1022 and the suture held therein with the suturepassing member 930 of the suturing instrument.

In some embodiments, in cartridge 2000, the rocker 1041 additionallydefines another alignment feature in the form of a rocker slot 1049 (asshown earlier in FIGS. 3J, 3L) within the groove 1044 to assist inalignment and transfer of the suture end 504 into the suture passingmember 930. The slot 1049 comprises a slit or channel 1049 a (also shownin FIG. 9A(i)) that exit into a side slot 1049 b within the rocker 1041,to aid in routing the suture 500 within the suture receiving groove 2025b (FIG. 8F(ii)) of the base 2020 to assist in aligning the suture withthe suture receiving slot 928 in the shaft. This allows the suture to beheld to the side of the suturing instrument 900 out of the way of thepath of the advancing suturing instrument during advancement of thesuturing instrument within the cartridge base 2020. As such the rocker1041 defines a rocker slot 1049 for routing the suture 500 there-throughto enable the suture 500 to be kept out of the way of a path of thesuturing instrument 900 upon advancement of the suturing instrument 900therein. For example when a portion of the instrument proximal portion910 is received within the groove proximal portion 1046 of the rockergroove 1044.

In one specific example, as shown in FIGS. 3J and 3K, the seat 1022 isdefined by a projection 1030 that is housed within the magazine 1021,specifically within the rocker 1041. As shown in FIGS. 3M and 4D, theprojection 1030 extends into the instrument receiving recess defined bythe groove 1044 (specifically, the groove proximal portion 1046). Morespecifically, the median functions to hold the projection 1030 withinthe groove proximal portion 1046 of the rocker. In some embodiments theprojection 1030 defining the seat 1022 may be formed in one piece aspart of the rocker. The projection 1030 additionally defines a bevelface 1034 for engaging with a bevel face 934 of the needle 930′ fordocking the needle 930′ to align the seat 1022 with the needle 930′ withto permit transfer of the suture end 504 from the seat 1022 into asuture receiving passage 932 of the needle 930′. In one specificexample, the projection 1030 is receivable into the instrument proximalportion or shaft 910 to facilitate alignment of the seat 1022 with theneedle 930′.

Alternatively, the rocker may define a seat recess or seat channel andan alignment recess 1030′ that is located adjacent the seat 1022. Asshown and described further herein with respect to FIGS. 3L and 3N, thealignment recess 1030′ is configured for receiving the suture passingmember 930 such as needle 930′ in its needle out configuration to alignthe seat with the suture passing member.

In some such embodiments, as shown in FIG. 3K, the rocker 1041 comprisesadditional alignment features such as interference features in the formof raised bumps 1045 a on the exterior of the projection 1030 that areconfigured to frictionally engage the interior of the instrumentproximal portion or shaft 910 with the needle 930′ as the projection1030 is received within the shaft 910. The rocker 1041 additionallycomprises additional raised bumps 1045 b along the interior of theproximal groove portion 1046 for frictionally engaging the exterior ofthe instrument proximal portion or shaft 910 once it is received withinthe proximal groove portion 1046. The raised bumps 1045 a, 1045 b helpto align the seat 1022 with the needle 930′.

In some embodiments projection 1030 defines a suture slot 1038 thereinallowing the suture 500 to exit therefrom to enable alignment of thesuture end 504 with the suture receiving passage 932 within the needle930′.

In some embodiments of the present invention, the rocker 1041additionally comprises interference tabs 1048 x ((as shown in FIG. 9A(iii), and FIG. 9B (i) as discussed earlier with respect to FIG. 3M) forengagement with the suturing instrument 900 which allow the rocker 1041to over-rotate to ensure alignment of the rocker 1041 with theinstrument proximal portion or shaft 910 of the suturing instrument 900to allow advancement of the rocker 1041 along the shaft 910. In otherwords the interference tabs 1048 x may allow the rocker 1041 to rotatesufficiently to enable the seat 1022 to be positioned adjacent thesuturing instrument 900 by ensuring that the shaft 910 is receivedwithin the rocker groove proximal portion 1046. For example where theseat 1022 is defined by the projection 1030, the interference tabs allowthe rocker 1041 to rotate sufficiently to enable the projection 1030 tobe received within the instrument shaft 910. Whereas, where the seat1022 is positioned adjacent an alignment recess (as discussed earlierwith reference to FIG. 3N, the interference tabs allow the rocker 1041to rotate sufficiently such that the alignment recess and the seat 1022adjacent to it are both aligned with the needle 930′.

As outlined previously herein, with reference to FIG. 8A-8C someembodiments of the present invention provide a housing sleeve 2011′ thatis detachably coupled to the base 2020 and remains coupled to the base2020 to operate as a single unit upon loading of the cartridge 2000 ontothe suturing instrument 900. The housing sleeve 2011′ remains coupled tothe base 2020 until the seat 1022 is aligned with the suture passingmember 930 of the suturing instrument 900. The cartridge sleeve 2011′ isdetachable from the base 2020 thereafter to transfer suture from base2020 into the suturing instrument 900. As such, the cartridge housing2010′ defines a suture transferring component 2011.

In some embodiments of the present invention as shown in FIG. 8B, thecartridge base 2020 is detachably coupled to the suture transferringcomponent 2011 of the housing 2010′ via an interlock 2050. The interlock2050 secures the base 2020 to the housing 2010′ in its initial position2050A may then be disengaged to move into its second position 2050B[shown later in FIGS. 9D [i], [ii]) to allow the housing sleeve 2011′that comprises the suture transferring component 2011 to translateindependently relative to the base 2020 to transfer the suture end 504from the seat 1022 into the suture passing member 930 of the suturinginstrument 900. FIGS. 9B [i], [ii] and 9C[i],[ii], illustrate theinterlock 2050 in its initial locked position 2050A, with an interlockarm 2056 being axially aligned with and being position distal to thebase 2020 preventing longitudinal movement of the base 2020 with respectto the housing 2010′. The interlock 2050 is moveable to its unlockedposition 2050B (as shown in FIGS. 9D [i], [ii]) to disengage thetransferring component from the base to enable relative movementthere-between upon alignment of the seat with a suture passing member ofthe suturing instrument. The function of the interlock 2050 is describedfurther herein below with respect to FIGS. 9C[i]-9D[ii]. In someembodiments, the interlock 2050 comprises a manual interlock that ismoveable into the unlocked position 2050B to manually disengage thesuture transferring component 2011 from the base 2020 upon alignment ofthe seat 1022 with the suture passing member 930.

In some embodiments, the interlock 2050 comprises an automatic interlock(FIG. 9A[i]) that functions to automatically disengage the suturetransferring component 2011 from the base 2020 upon alignment of theseat 1022 with the suture passing member 930. In some such embodiments,the operation of the interlock 2050 is partially automatic wherein theinterlock 2050 comprises an interlock tab 2054 (as shown in FIG. 9A[i]),that is automatically disengaged upon alignment of the seat 1022 withthe suture passing member 930 to enable the interlock 2050 to be movedmanually into its unlocked position 2050B (FIG. 9E[i]). This enables thebase 2020 to be disengaged from the suture transferring component 2011.More specifically, the rocker 1041 comprises a rocker bar 2055 that ismoveable upon alignment of the seat 1022 to disengage the interlock tab2054. This is discussed further herein below with reference to FIGS.9A[i]-9B [ii].

In some embodiments, as shown in FIG. 9A[i], the suture transferringcomponent 2011 comprises a push rod 2058, wherein the suturetransferring component 2011 is moveable with respect to the base 2020 toenable movement of the base 2020 therein to engage a push rod 2058 topush the suture end 504 held within the seat 1022 to transfer it to thesurgical suturing instrument 900. In some such embodiments the push rod2058 comprises a push rod hub 2057 that is configured to translatewithin push rod cavity 2057′. In some such embodiments, the suturetransferring component 2011 comprises a sleeve push hub 2012 to push thepush rod hub 2057 once in engagement therewith. In some embodiments thepush sleeve hub 2012 is moveable within a sleeve cavity 2012′ and isbiased towards the base 2020. In one specific example the push sleevehub 2012 is biased via a spring mechanism. In a specific instance ofthis example, the spring mechanism comprises two springs 2013. The pushsleeve hub 2012 is configured to push the push rod hub 2057 upontranslation of the suture transferring component 2011 with respect tothe base 2020. As such the suture transferring component 2011 comprisesa hub, such as sleeve push hub 2012 that is biased towards the base 2020to push the push rod 2058 upon engagement with the push rod 2058 upontranslation of the base 2020 within the housing sleeve 2011′. In oneexample, the sleeve push hub 2012 is biased via a spring mechanism.

In one specific example, the push rod 2058 comprises a longitudinallyextending wire 2053′ coupled to the push rod hub 2057 that istranslatable within a wire channel 2053 in communication with the seat1022 for receiving the wire 2053′ therein to push the suture end 504held within the seat 1022 into a suture receiving passage 932 of thesuturing instrument 900. As such the cartridge 2000 comprises a suturetransferring component 2011 defines a push mechanism as described hereinabove. The push mechanism is defined as the mechanism of the cartridgethat enables a pushing force to be applied to the suture portion such asthe suture end to transfer from the seat into the suturing instrument.In one such example the push mechanism comprises a push rod 2058 asdescribed above.

In some embodiments, the cartridge 200 is configured to align andtransfer the suture end 504 upon a single linear movement of thecartridge 2000 with respect to the suturing instrument 900. As outlinedabove in some such embodiments surgical suturing instrument 900comprises a suture passing member 930 defining a suture receivingpassage 932 wherein the suture transferring component 2011 that isoperable to transfer an end of the suture 500 from the seat 1022 withinthe base 2020 into the suture receiving passage 932 of the suturinginstrument 900.

In some embodiments of the present invention, as shown in FIG. 8C, theknot slider 2030 is coupled to the suturing instrument 900. In one suchexample the knot slider 2030 configured to be slidably engaged with aportion of the surgical suturing instrument to allow the knot slider2030 to be mounted thereon. In one particular example, the knot slider2030 is engageable in sliding contact with a portion of the suturinginstrument 900 for positioning the knot slider 2030 along the suturinginstrument to facilitate deployment of the pre-tied knot 502 from theknot slider 2030. In one specific example, the knot slider 2030 isengageable in sliding contact with the suturing instrument via an arm2034 that is receivable within an opening/window or groove 965 [FIG. 1C]along the side of the instrument proximal portion 910. The knot sliderarm 2034 enables positioning of the suturing instrument along the tissuereceiving gap 942 to facilitate deployment of the pre-tied knot from thesuturing instrument 900 during use. Furthermore in some embodiments, theknot slider arm 2034 is housed within a slider groove 2036 and comprisesan inner position 2034A where it is housed within the slider groove 2036[FIG. 8D, FIG. 11A]. The knot slider arm 2034 additionally and an outerposition 2034B where it extends proximally (at least partially) from theslider groove 2036 [FIG. 11B] to allow the knot slider 2030 to bepositioned over the tissue receiving gap 942.

In some embodiments the suture is contained within tubing mounted on theinside the knot slider 2030. The cartridge 2000 stores the suture limbswithin the knot slider 2030 for example inside a polytetrafluoroethylene(PTFE) tube that may be coiled and mounted about an internal post 2037an internal knot slider 2030 x that defining a passage 2037′ about itonce it is press fit inside the external knot slider 2030 y as shown inFIG. 11 .D The PTFE tube may allow the suture to be released with aconstant and small force. In the embodiments, the force of the suturepayout may not be constant. In some embodiments, a silicone O-ringprovides a dampening effect on the release of the suture to achieve asmoother, more constant force of release and to retain tautness in theSuture throughout the procedure.

In some embodiments, as described herein above in example 3, themovement of the suturing instrument 900 may be a relative movement withrespect to the cartridge 2000, with reference now to example 4. In otherwords the user may move the cartridge 2000 axially over the suturinginstrument 900 in a proximal direction while the suturing instrument isheld by the user in order to create a relative advancement of thesuturing instrument 900 with respect to the cartridge 2000 in order toload the suture onto the suturing instrument 900. This may be referredto as loading of suture using pumping action. As such, the mechanism ofloading of the suture may remain as described above but the movement maybe created either by the proximal movement of the cartridge over thesuturing instrument or the distal movement of the suturing instrumentwithin the cartridge.

In some embodiments of the present invention as described herein, thecartridge is configured to align and transfer the suture upon a singlelinear motion of the cartridge with respect to the suturing instrument.In some such embodiments, an interlock 2050 may be automaticallydisengaged upon alignment of the suture end within the seat with thesuture passing member to enable automatic transfer of the suture end 504into the suture passing member (due to advancement of the base andactivation/engagement of the push rod) as the housing 1010′ is continuedto be pulled proximally. Additionally the cartridge enables a pre-tiedknot be mounted onto the suturing instrument during the same linearmovement of the cartridge. The mechanism provided may be similar to themechanism described herein above with respect to the knot slider 2030.Thus, embodiments of the present invention may comprise a cartridge thatis operable to transfer suture portion such as the suture end 504 fromthe seat 1022 into the suture passing member 930, which would allow thesuturing instrument to be able to pass the suture in order to suturetherewith, as well as enable a pre-tied knot to be mounted onto thesuturing instrument. In some such embodiments, the cartridge is loadedonto the suturing instrument 900 with a single linear movement. In somesuch embodiments a single pumping action is used involving a singlelinear relative movement of the cartridge onto the suturing instrument(to transfer the suture end mount the pre-tied knot) and linear movementthe cartridge 2000 [in a direction opposite to the loading direction]thereafter leaving the knot slider 2030 coupled to the suturinginstrument 900 for example to mount a pre-tied knot held therein ontothe suturing instrument. As such the remainder of the cartridge 2000other than the knot slider 2030 is removed.

A further example of a side load alignment mechanism 1100″ is shown inFIGS. 12A-12F. The 1121 magazine defines a button 1123 shown in itsinitial position 1121A [FIG. 12A, 12E] comprising a side loading slidingseat 1122′ [FIG. 12B]. The base 1120 defines a magazine recess 1127defining a magazine cavity 1127′ and the magazine 1121 is moveablewithin the magazine recess. Initially, the instrument is advanceableinto the base recess 1025 that functions as a restraint to maintain theposition of the suturing instrument 900 as it is advanced distallywithin the base 1120. Upon loading of the cartridge onto the suturinginstrument the magazine [FIG. 12C] the cavity 1127′ corresponds to thetissue receiving gap 942. In other words, once the suturing instrument900 is advanced within the base 1120 the tissue receiving gap 942 of thesuturing instrument 900 is positioned within the magazine cavity 1127′[As shown in FIG. 12C]. The magazine 1121 is then moveable sideways intothe magazine cavity 1127′ to align the seat 1122′ with respect to thesuturing instrument 900. FIG. 12D illustrates a side view of the base1120 with the button in its depressed or second position 1121A and FIG.12E illustrates an end view of the same.

Thus as outlined herein above with reference to Examples 3 and 4, inaccordance with some embodiments of the present invention, a mechanismis provided for providing both alignment and insertion that mayfacilitate ease of use by reducing: the number of user steps required,requirements for user dexterity and concentration and in someembodiments additionally facilitates use by providing only one possibleorder of performing the user steps.

In order to load suture into a surgical suturing instrument or suturepasser, in accordance with some embodiments of the present invention asoutlined herein below in Examples 3 and 4, two events or functions takeplace: (1) alignment of the suture portion held within the cartridgewith a suture receiving feature within the surgical suturing instrumentor the suture passer and (2) insertion of the suture portion into thesuture receiving feature within the suturing instrument or suturepasser.

Example 5

Features of this example as illustrated in FIGS. 13A-13G are similar tothose described earlier, for example with respect to Examples 3 and 4.In addition, Example 5 includes various alternatives to featuresdescribed above and/or additional features not previously mentioned,including but not limited to: movement of the magazine, for example therocker, alignment of the seat and/or rocker, reversibility-preventionfeatures when suture has not been loaded, coupling of the rocker to thepush-rod hub, indicator for indicating loading or transfer of sutureonto the suturing instrument, interlock to prevent insertion of thesuturing instrument in an incompatible orientation and features relatedto the knot slider. Each of these features will be presently describedin greater detail with reference to the accompanying figures.

Referring initially to FIG. 13A, a cartridge 4000 is shown that isusable for loading a portion of a suture onto a suturing instrument,such as suturing instrument 900 described previously herein aboveSimilar to the embodiment discussed in example 4, the cartridge 4000comprises a housing 4010′ that comprises a housing sleeve 4011′ and aknot deployment mechanism such as a knot slider 4030, with the housing4010′ defining a chamber 4010 for axially receiving the surgicalsuturing instrument 900 therein and a means for securing or mounting apre-tied knot 502 (FIG. 13B) about the chamber 4010. In someembodiments, the knot deployment mechanism or knot slider 4030 isdetachably coupled to the cartridge housing sleeve 4011′ by a couplingmechanism comprising a knot slider release mechanism 4060 as shown.

The cartridge 4000 as shown in FIG. 13B defines a path for insertion ofthe suturing instrument 900 within the cartridge 4000 and to facilitateremoval of the suturing instrument 900 therefrom. In one such example,the path comprises a linear path and may be partially defined by thechamber 4010. The cartridge 4000 additionally comprises a magazine 4021which defines a seat 4022 for releasably holding a portion of a suture.The magazine 4021 comprises a rocker 4041 as shown in FIG. 13B. Rocker4041 is similar to the rocker 1041 illustrated in Example 4;significantly, however, unlike embodiments described previouslyhereinabove, the embodiment of the cartridge shown in FIG. 33B lacks abase and the rocker 4041 is held directly within the cartridge housing4010′ and is directly coupled to the housing 4010′. In addition,cartridge 4000 includes a translation mechanism 4085 for moving rocker4041 and seat 4022 in a controlled and constrained manner. In thecontext of the present disclosure, a translation mechanism is a featureor component that allows for movement, including but not limited tolinear or rotational movement. The translation mechanism 4085 allows forthe seat 4022 to move out of the path of the suturing instrument 900 forwithdrawal of the suturing instrument 900 from the cartridge 4000. Inaddition, the translation mechanism 4085 enables movement of the rocker4041 to move the seat 4022 into alignment with the suturing instrument900 upon advancement of the suturing instrument 900 within the cartridge4000. The suturing instrument 900 may be of the type describedpreviously herein above with reference to FIGS. 1C-1E, where theinstrument comprises a proximal portion 910, and a distal portion 920coupled thereto with a tissue receiving gap 942 defined there-betweenfor receiving a tissue to be sutured. When used with such a suturinginstrument, the translation mechanism 4085 enables movement of seat 4022into and out of the tissue receiving gap 942 to allow for alignment ofthe seat with the suturing instrument and withdrawal of the suturinginstrument, respectively.

In the particular example shown, as further illustrated in FIGS.13C-13F, the translation mechanism 4085 comprises a rotationalmechanism. Alternatively, in other embodiments, for example as shownpreviously in FIGS. 4A-4C, the translation mechanism may comprise aspring biased mechanism operable for linear movement. In one example ofa rotational translation mechanism, the rotational translation mechanismincludes an arcuate track 4080 defined by the cartridge housing 4010′,and one or more laterally extending pins 4082 defined by the rocker 4041that are receivable within the track 4080. More specifically, in such anembodiment, the housing sleeve 4011′ of the cartridge housing 4010′includes a groove or track 4080 formed by ribs 4081, that defines acurved path, i.e. a path where at least a portion is curved. Whenassembled, the track 4080 receives rocker pins 4046′ and functions toallow the rocker 4041 to rotate in a pivoting manner while remainingconstrained by the track 4080 within the housing 4010′. In such anembodiment, the rotational translation mechanism 4045 allows the rocker4041 to move between a first position 4041A, as shown in FIG. 13B andFIG. 18F, for positioning the seat 4022 out of the path of the suturinginstrument, and a second position 4041B, as shown in FIG. 18C (i) andFIG. 18D(ii), for positioning the seat 4022 in alignment with a portionof the suturing instrument 900, such as the instrument proximal portion910. More specifically, the rocker 4041 is moveable from its firstposition 4041A shown in FIG. 18Ai), 18Aii) where the seat 4022positioned out of the path of the suturing instrument 900, into itssecond position 4041B where the seat is in alignment with the suturinginstrument 900 and positioned within the tissue receiving gap 942 asshown in FIGS. 18Ci), 18Cii). FIGS. 18Bi) and 18Bii) indicate theposition of the rocker 4041 in its intermediate position as it movesfrom its first position 4041A towards its second position 4041B. FIGS.18Aii) and 18Bii) and 18Cii) illustrate the position of the rocker 4041and the suturing instrument 900 in isolation from the remainder of thecartridge 4000 in order to provide additional clarity. The rocker 4041further allows the seat 4022 to be moved out of the path of the suturinginstrument 900 after the suture portion has been transferred to thesuturing instrument 900. More specifically, the rocker 4041 is pivotablefrom its second position 4041B to its first position 4041A to allow theseat 4022 to be moved out of the tissue receiving gap 942 of thesuturing instrument 900 to allow retraction of the suturing instrument900 as shown in FIGS. 18E and 18F. Referring now to FIGS. 13C-13E, inthe illustrated embodiment, rocker 4041 includes a resilient member orflex-arm 4031 that is operable to engage with the cartridge housing4010′, for example with a locking rib 4031′ within the housing sleeve4011′. Resilient member 4031, in cooperation with locking rib 4031′,thus functions to maintain rocker 4041 in a desired initial or firstposition 4041A which facilitates unimpeded advancement of the suturinginstrument 900. Movement of the rocker 4041 is otherwise similar to thatof rocker 1041 described herein with respect to FIGS. 9A [i]-9B [ii].

As shown in FIG. 13G, which illustrates a partial cut-away view of therocker 4041 along a longitudinal axis of the rocker, with a left sideportion of the rocker 4041 being visible. The rocker 4041 defines afirst or distal bevel face 4043 facing towards the interior of a rockergroove 4044, and more specifically defines a distal wall of the groovedistal portion 4048, similar to bevel face 1043 discussed previouslyhereinabove with reference to FIG. 9A (i). In some embodiments, thedistal portion of suturing instrument 900 is configured to interact withthe first bevel face 4043 upon advancement of the suturing instrument900 within the cartridge 4000 as shown in FIGS. 18Ai), 18Aii) whichillustrate the rocker 4041 in a partial breakaway view with the rocker4041 being shown in. This results in pivoting of the rocker 4041 fromits first position 4041A illustrated in FIGS. 18Ai), 18Aii) into itssecond position 4041B illustrated in FIGS. 18Ci), 18Cii), andconsequently results in movement of the seat 4022 into the tissuereceiving gap 942, to align the seat 4022 with the proximal portion 910of the suturing instrument 900. In addition, the rocker 4041 defines asecond or proximal bevel face similar to bevel face 1043′ shown in theembodiment illustrated in FIG. 10B, which faces towards the interior ofthe rocker groove 4044, and more specifically defines a proximal wall ofthe groove distal portion 4048. The second bevel face is formed in aright side portion of the rocker 4041 [not visible in FIG. 13G]. In someembodiments, the distal portion 920 of suturing instrument 900 isconfigured to interact with the second bevel face upon retraction of thesuturing instrument 900 from the cartridge 4000. This results inpivoting of the rocker 4041 and consequent movement of the seat 4022 outof the tissue receiving gap 942 and back into its first position 4041A,whereby the seat is moved out of the path of the suturing instrument900, as illustrated in FIGS. 18E and 18F.

Referring now to FIG. 13B-13G, general alignment concepts are shown asthey relate to the alignment of the rocker 4041 and thus the seat 4022with respect to the suturing instrument 900. The cartridge 4000comprises several alignment features to facilitate alignment of the seat4022 with a portion of the suturing instrument 900 to permit transfer ofa suture portion held within the seat 4022 onto the suturing instrument900. In one particular example, the alignment feature comprises aninstrument guiding feature to guide the suturing instrument within thecartridge 4000. In some embodiments, the instrument guiding feature isdefined by the magazine 4021 such as the rocker 4041. In one suchexample, the instrument guiding feature comprises one or resilientmembers 4035 that extend from the magazine 4021. In one particularexample, the one or more resilient members 4035 comprise one or morehorizontally aligning side arms 4037 for aligning the suturinginstrument horizontally with the seat 4022. The side arms 4037 guide theshaft or instrument proximal portion 910 of the suturing instrument 900up to seat 4022 such that the seat cavity or recess 4022′ defined by theseat 4022, is horizontally or laterally aligned with the instrumentproximal portion 910. In the particular example shown in FIG. 13G, thehorizontally aligning side arms 4037 extend from the rocker 4041 suchthat they straddle the suturing instrument 900 along its sides uponinsertion of the suturing instrument 900 within the cartridge 4000.Additionally, in some embodiments, as shown for example in FIGS.13H-13J, the rocker 4041 may comprise the one or more resilient members4035 that comprise one or more vertically aligning side arms 4039 foraligning the suturing instrument vertically with the seat. In one suchexample, the one or more side arms 4039 comprise a downwardly extendingflex arm for engaging an upper surface of the suturing instrument 900.As such, either or both of the horizontally aligning side arms 4037 andvertically aligning side arms 4039 enable alignment of the suturepassing member such as needle 930′ and the suture receiving recess 932defined thereby, with the seat cavity or recess 4022′ which is moveableinto the tissue receiving gap 942 of the suturing instrument 900 asshown in FIG. 13B.

In alternative embodiments, as shown in FIGS. 13H to 13J, the one ormore horizontally aligning side arms 4037 may comprise an alternateconfiguration. In one such example, the side arms 4037A are shown thatextend from an upper surface or top portion 4041 t of the rocker 4041.In one such example the side arm 4037A defines a slot s for routing andguiding suture to the side of the rocker 4041. In another example, sidearms 4037B are provided that extend distally from a front or proximalface 4041 p of the rocker 4041, as shown in FIG. 13I. Alternatively, insome embodiments, the one or more side arms 4037C may extend proximallyfrom an intermediate portion 4041 i of the rocker 4041 that ispositioned distal to the proximal face 4041 p of the rocker 4041, asshown in FIG. 13J. Furthermore, as shown in FIGS. 13H to 13J, in someembodiments the one or more side arms 4037A, 4037B and 4037C extend intoa space or gap 4041 g.

In other embodiments, the instrument guiding feature is defined by thecartridge housing 4010′. In one such example, as shown in FIGS. 13B and13F, the instrument guiding feature comprises guiding ribs 4036 withinthe housing sleeve 4011′ of cartridge housing 4010′. The suturinginstrument 900 is guided and constrained by ribs within the cartridgehousing 4010′. The guiding ribs 4036 may be provided such that theyaccommodate suturing instruments 900 of varying surfaces flatness andmay additionally help prevent binding of the suture. The guiding ribs4036 function to guide the suturing instrument 900 into alignment withthe rocker 4041. In some embodiments the cartridge 4000 additionallycomprises a suture guiding or routing feature to allow the suture to berouted within the cartridge 4000. In one such example, the sutureguiding feature is also defined by the guiding ribs 4036. The guidingribs 4036 provide clearance for the suture to run from (in someembodiments, a pre-tied knot mounted on) the knot slider 4030 to therocker 4041.

In other embodiments, as shown in FIG. 13D, additional instrumentguiding features are defined by the magazine 4021/rocker 4041. Forexample, the rocker 4041 defines a locking recess 4044 for receiving aportion of the suturing instrument 900 in press-fit engagement foraligning the seat with the portion of the suturing instrument. Thelocking recess 4044 is defined by the edge 4044′ Similar to embodimentsdiscussed previously herein above with reference to FIG. 3H to FIG. 3K,the magazine 4021 comprises a projection 4030′ defining the seat 4022,as shown in FIG. 13G. In one such example, the projection 4030′comprises one or more reference features 4045 a for engaging with aninterior of a portion of the suturing instrument 900 for aligning theseat 4022 with the portion of the suturing instrument 900.

In addition to comprising instrument guiding features, referring againto FIG. 13G, the rocker 4041 additionally defines a channel 4053 incommunication with the seat 4022 for allowing movement of a push rod4053′ there-through for advancing a suture end from the seat 4022 intothe suturing instrument 900. Furthermore, in some embodiments as shownin FIGS. 13K and 13L, the rocker 4041 comprises lateral halves 4041 h 1,4041 h 2 that are configured to co-operatively engage with one anotherto form the rocker 4041. In some such embodiments as shown, the lateralhalves 4041 h 1, 4041 h 2 engage one another via a snap fit or press fitmechanism 4050. As illustrated the snap fit mechanism 4050 comprises atab 4052 that is receivable within an opening 4051 to be engagedthere-with.

Alternative embodiments of the rocker 4041 are shown in FIGS. 14A-14G.In one particular embodiment as shown in FIG. 14A, the seat 4022comprises a seat cavity or seat recess 4022′ that is defined by therocker 4041, where the seat cavity or seat recess 4022′ is incommunication with the wire channel 4053 and extends from the wirechannel 4053. In an alternate embodiment, the seat 4022 is defined by atubular member 4022 a, as shown in FIG. 14B, that defines an aperture4022 a′ that is in communication with the wire channel 4053. FIG. 14Cillustrates a further alternative embodiment, wherein tubular member4022 a comprises a sleeve 4022 b that can be inserted within the rocker4041 to form the seat 4022. The sleeve 4022 b defines an opening 4023 inorder to provide strain relief to allow it to bend without constrictingthe inner tube diameter and thus it provides flexibility within thetubular member for ease of insertion and assembly of the seat 4022within the rocker 4041.

In some embodiments, as shown for example in FIG. 13G, the rocker 4041comprises a rocker body 4041 b and an insert 4041 n defining the seat4022. The insert 4041 n defines a wall or median 4047 that allows aportion of the suturing instrument to rest there-against to facilitatealignment, with the instrument distal portion 920 being received in adistal groove portion 4048, the proximal portion 910 being received in aproximal groove portion 4046 and the seat 4022 being positioned withinthe tissue receiving gap 942, as shown in FIG. 18C(i). In alternateembodiments, as shown for example in FIG. 14D, the insert 4041 n definesa rocker recess 4024 for receiving a portion 4024′ of the rocker body4041 b therein for securing the insert 4041 n within the rocker body4041 b. In some such embodiments, the seat insert 4041 n comprises asingle unit that is receivable within the rocker 4041. In otherembodiments, the insert 4041 n further comprises a hub 4025 that iscoupled to a tubular member defining the seat 4022 using a couplingmechanism. In one such example, as shown in FIGS. 14E and 14F, thetubular member may comprise a tubular member 4022 a similar to theembodiment illustrated in FIG. 14B. In other embodiments, as shown inFIG. 14G, the tubular member may comprise a sleeve 4022 b of the typeshown in FIG. 14C that is coupled to the hub 4025, with the sleeve 4022b comprising a cut-out or notch/opening 4023 to provide feature for theglue to adhere to, whereas the opening within sleeve 4022 b that opensinto the channel 4053 provides clearance for a push rod to enter thesleeve 4022 b.

In some embodiments, the seat 4022 and the hub 4025 each comprise apolymer. In one specific example, the polymer comprises Acrylonitrilebutadiene styrene (ABS). In some such embodiments, the couplingmechanism for coupling the hub and the tubular member comprises apolymer weld. Alternatively, the seat 4022 and the hub 4025 may eachcomprise a metal such as stainless steel, wherein the coupling mechanismmay comprise a metal weld such as a laser weld for example asillustrated in FIG. 14F. In other embodiments, the coupling mechanismmay comprise an adhesive 4028 such as glue, as shown in FIGS. 14E and14G. In some embodiments, for example in any of the embodiments shown inFIGS. 14A-14G, the wire channel 4053 (not labeled in all figures) inconjunction with the seat cavity 4022′ comprises a substantiallys-shaped configuration.

In further embodiments of the present invention, additional features areprovided in a cartridge 4000 for facilitating loading of suture onto asuturing instrument 900. For example, as shown in FIGS. 15Ai) to15Ciii), the cartridge 4000 additionally comprises an instrumentretention mechanism 4070 that is configured to permit advancement of asuturing instrument 900 into the cartridge 4000 and to prevent prematureretraction or withdrawal there-from until the suture portion is loadedonto the suturing instrument 900. In some embodiments, the instrumentretention mechanism 4070 comprises a lock such as a biased lockingelement 4072′ that is moveable away from or out of the path of theadvancing suturing instrument 900 to allow substantially unimpededadvancement of the suturing instrument 900 within the cartridge 4000.FIGS. 15Ai) through 15Aiii) illustrate the locking element 4072′ in itsinitial position prior to advancement of the instrument within thecartridge. FIGS. 15Bi) through 15Biii) illustrate the locking element4072′ moved out of the path of the instrument as the instrument isadvanced. In one such example, the biased locking element 4072′comprises a resilient member that flexes, bends or otherwise moves outof the way of the advancing suturing instrument 900 to allow the distalportion 920 of the suturing instrument 900 to advance past the biasedlocking element 4072′. In some embodiments, for example as illustratedin FIGS. 15Ci) through 15Ciii), once the distal tip 920 and the tissuereceiving gap 942 advance past the biased locking element 4072′, thebiased locking element 4072′ is configured to engage the proximalportion 910 of the suturing instrument 900, specifically a window orgroove 955 of the suturing instrument 900 to thereby substantiallyprevent, obstruct or limit retraction of the suturing instrument 900prior to loading of suture onto the suturing instrument 900.

In some such embodiments, a lock release mechanism is provided in orderto disengage the lock. For example, a lock release mechanism is providedthat may be manually operable to disengage the biased locking element4072′ from the window or groove 955. In other embodiments, a lockrelease mechanism is provided that is configured to automaticallydisengage the lock upon transfer or loading of the suture portion ontothe suturing instrument 900. In some such embodiments, for example asshown in FIG. 15Ai), the lock release mechanism comprises a springbiased component such as a release arm 4076 that is coupled to a biasingmechanism 4090. The biasing mechanism 4090 is operable to move therelease arm 4076 upon transfer of the suture portion to disengagelocking element 4072′ from the suturing instrument 900.

In a specific example shown in FIGS. 16A-16D, a biased locking elementis provided that comprises a rotational locking mechanism 4074, whereinthe rotational locking mechanism 4074 comprises a rotatable swing arm4075, terminating in a tab 4075 t. In one such example, the rotatableswing arm 4075 is biased via a torsion spring. In the illustratedembodiment, the swing arm 4075 is moveable out of the way or path (asillustrated in the dashed outline provided in FIG. 16B) of the suturinginstrument 900 in order to allow advancement of the suturing instrument900 within the cartridge. In some such embodiments, tab 4075 t defines abeveled surface. In use, once the distal portion and the tissuereceiving gap of the suturing instrument 900 are positioned distal ofthe tab 4075 t, the swing arm 4075 is moved into the path of thesuturing instrument 900 such that tab 4075 t engages with the window orgroove 955. A release arm 4076 is moveable adjacent the swing arm 4075to prevent rotation thereof for maintaining the tab within the groove orwindow 955. As such, the swing arm 4075 functions to lock the suturinginstrument 900 within the cartridge to prevent retraction or withdrawalof the suturing instrument 900 prior to loading of the suture onto thesuturing instrument 900. As shown in FIG. 16C, the release arm 4076 isthen translatable or moveable away from the swing arm 4075 to allowrotation thereof to permit disengagement of the tab from the suturinginstrument 900 to permit retraction and removal of the suturinginstrument 900 from the cartridge. Alternatively, the lock may comprisea resilient member biased for engaging with the suturing instrument 900and the release arm may be operable to allow disengagement of theresilient member from the suturing instrument.

In a further alternative as shown in FIGS. 17A-17C(ii), the lockcomprises a resilient member 4079 such as a resilient arm for engagingwith the suturing instrument 900 for example with the window or groove955 of the suturing instrument 900. Furthermore, a lock releasemechanism 4077 is provided for disengaging the member 4079 upon transferof the suture portion onto the suturing instrument 900. The lock releasemechanism 4077 comprises a spring biased block 4079′ that in its initialposition 4079′A (FIG. 17A) supports the resilient member 4079 andprevents its movement in the proximal direction. As the instrument 900is advanced distally through the cartridge, the resilient member 4079flexes to allow the distal portion 920 of the suturing instrument 900 toadvance, as shown in FIG. 17A, and resilient member 4079 is thereafterengageable with the window 955 of the suturing instrument 900 to preventretraction of the suturing instrument 900, as shown in FIGS. 17B (i),17B (ii). The block 4079′ remains in its initial or locked position4079′A substantially adjacent the resilient member 4079 to preventbending of the resilient member 4079 in the proximal direction toprevent retraction of the suturing instrument 900 prior to loading ofsuture onto the suturing instrument 900. Once a suture portion has beenloaded onto the suturing instrument 900, the spring biased block 4079′,forming the lock release mechanism 4077, moves into its second orunlocked position 4079′B, as shown in FIGS. 17C(i), 17 c(ii), where itno longer interferes with the movement of the resilient member 4079allowing it to flex proximally, thereby permitting retraction of thesuturing instrument 900.

In some embodiments of the present invention, the cartridge includes adelay mechanism to delay transfer of the suture from the cartridge ontothe suturing instrument until after the seat, defined by the rocker, isaligned with the suturing instrument 900. More specifically, the delaymechanism prevents actuation of the suture insertion mechanism totransfer the suture from the seat to the instrument prior to alignmentof the seat with the suture passing member held within the proximalportion of the suturing instrument.

As outlined previously hereinabove, in some embodiments of the presentinvention, the distal portion 920 of suturing instrument 900 isconfigured to interact with a bevel face of the rocker such as the firstbevel face 4043 of rocker 4041 upon advancement of the suturinginstrument 900 within the cartridge 4000 as shown, for example, in FIGS.18Ai), 18Aii). The rocker 4041 in FIGS. 188Ai)-18Bii) is shown in apartial breakaway view with the front half of the rocker 4041 beingremoved. This results in pivoting of the rocker 4041 from its firstposition 4041A, illustrated in FIGS. 18Ai), 18Aii), into its secondposition 4041B illustrated in FIGS. 18Ci), 18Cii), resulting in movementof the seat 4022 into the tissue receiving gap 942 to align the seat4022 with the proximal portion 910 of the suturing instrument 900(specifically with a suture passing member such as needle 930′). Anintermediate position of the rocker 4041 is illustrated in FIGS. 18Bi),18Bii) during movement of the rocker 4041 from the first position 4041Atowards its second position 4041B.

Upon movement of the seat 4022 into the tissue receiving gap 942, thesuturing instrument 900 is advanced distally in order to allow for theneedle 930′ to be positioned or docked adjacent the seat 4022, forexample in abutting contact with the seat 4022 as shown in FIG. 18Cii).Thus, the difference between the cartridge 4000 as shown in FIGS. 18Ci)and 18Cii) is that in FIG. 18Ci) the needle 930′ and the seat 4022 areat the point at which they are aligned but not yet docked, whereas inFIG. 18Cii) the suturing instrument 900 has been advanced further toallow the needle 930′ to dock with the seat 4022. In some embodiments,the suture transfer or insertion mechanism is delayed until suchalignment occurs, and is then actuatable to transfer or load the sutureportion from the seat 4022 onto the suturing instrument 900. In somesuch embodiments, the delay mechanism for delaying actuation of thesuture insertion mechanism comprises a delay interlock 4095 mounted onthe suture insertion mechanism which, in the illustrated example,comprises a push rod hub 4057′ coupled to a push rod 4053, as shown inFIGS. 13C and 13D. In one specific embodiment, the delay interlock 4095comprises a resilient member 4096 coupled to or integral with the pushrod hub 4057′, the resilient member 4096 (such as a push rod hub flexarm) being configured to co-operatively engage a protrusion 4097 coupledto the rocker 4041 ((Also shown in FIG. 13C and FIG. 18C(ii)), wherebythe protrusion 4097 can be understood to be indirectly coupled to theseat 4022). As shown in FIG. 18Cii), the resilient member 4096 ispositioned distal to the protrusion 4097 in a first, or unactuated,state of the suture insertion mechanism Once the seat 4022 is alignedwith the needle 930′ and in abutting contact with the needle 930′, asshown in FIG. 18D(i), the suturing instrument 900 may be advanceddistally within the cartridge 4000, causing the push rod hub 4057′ tocontact a spring hub 4100 and to thereby apply a force to hub 4100 (and,consequently, to spring 4103) as the instrument 900 is further advanced.Once sufficient force is applied by the push rod hub 4057′, as shown inFIG. 18D(ii), spring hub 4100 is pushed distally and protrusion 4097 isadvanced beyond resilient member 4096, such that resilient member 4096is positioned proximal to the protrusion 4097. The suture insertionmechanism is now in its second or actuated state resulting in the pushrod hub 4057′ moving within the push rod hub cavity 4057 shown in FIG.13 .G due to the biasing force of spring 4103 against hub 4100. Movementof the push rod hub 4057′ then results in translation of the push rod4053′ coupled thereto to advance the suture portion, such as a sutureend 502 comprising compressed suture, from the seat 4022 into or ontothe needle 930′. Thus, in such embodiments, actuation of the sutureinsertion mechanism, and consequent transfer of the suture, is delayeduntil the delay interlock is positioned appropriately, which occursfollowing alignment of the seat with the needle 930′.

Some embodiments of the present invention additionally comprise one ormore features to provide the user with an indication that the sutureportion, such as the suture end 502 [shown, for example, in FIG. 13G]has been transferred from the seat 4022 onto the suturing instrument900. In some such embodiments, the cartridge 4000 comprises an indicatorfor indicating transfer of the suture onto the suturing instrument 900.The indicator may comprise one or more of a tactile indicator, a visualindicator or an audible indicator. In one such example, the indicatorcomprises a tactile indicator comprising a force release mechanism 4200as shown in FIGS. 18D(i) and 18D(ii). In the illustrated embodiment, aforce release mechanism 4200 comprises a spring biased mechanism definedby the spring hub 4100 which itself comprises outwardly extending hubflex arms 4102 as well as a spring 4103. The force release mechanism4200 provides an indication of a change in a force, which may be felt bythe user, between the unactuated state of the suture insertion mechanismand the actuated state of the suture insertion mechanism as discussedhereinabove. More specifically, the force release mechanism 4200 isconfigured such that the user is able to feel a change in force once thepush rod hub 4057′ moves from its initial unactuated position shown inFIG. 18D(i) towards its actuated position as shown in FIG. 18D(ii) fortransferring the suture portion from the seat 4022 into the needle 930′.

In some embodiments, after transfer of the suture portion to thesuturing instrument, the suturing instrument 900 is operable to beadvanced distally. As illustrated in FIGS. 18D(i) and 18D(ii), furtheradvancement causes the outwardly extending hub flex arms 4102 of thespring hub 4100 advance beyond ledges or ribs 4102′ defined by thecartridge housing 4010′ causing the spring 4103 to compress. Themovement of the hub flex arms 4102 beyond the ledges 4102′, combinedwith the concurrent compression of the spring 4103, results in a forcedifferential that is felt by the user handling the instrument 900, asthere is a reduction in resistance force upon further advancement of thesuturing instrument 900. This reduction in force provided by the forcerelease mechanism provides the user with a tactile feel indicating thatthe suture portion has been transferred onto the suturing instrument900. Furthermore, in some examples the force release mechanism 4200additionally provides an audible indication as the hub flex arms 4102ride over the ledges 4102′, whereby the force release mechanismadditionally defines a snap release mechanism. In the illustratedembodiment, the tactile and/or audible indicators are not activatedimmediately upon transfer of the suture portion; rather, the indicationis delayed until the instrument is further advanced within thecartridge. In such embodiments, the cartridge 4000 comprises a delaymechanism to delay activation of the indicator (for example for apredetermined time period) following loading of the suture portion fromthe cartridge onto the suturing instrument 900. This provides a safetyand security feature in terms of ensuring that the suture has beenloaded prior to an indication being provided to the user to indicatetransfer of the suture portion. In other words the indication provides asafety factor to account for dimensional and force variability.

In additional embodiments of the present invention, a visual indicatoris provided, comprising a button 4106 including a spring biasedmechanism 4106′. In the illustrated embodiment, the spring biasedmechanism is configured to cause the button 4106 to be released,allowing it to move from its initial position 4106A [FIG. 18C (ii)] toits second position 4106B [FIG. 18D(ii)], upon transfer of the sutureportion onto the suturing instrument 900, thereby providing a visualindication of the suture transfer. In some embodiments, the visualindicator 4106 cooperates with the force release mechanism 4200, wherebyvisual indicator 4106 is released into its second position 4106B uponmovement of the force release mechanism 4200. For example, asillustrated in FIGS. 18D(i) and 18D(ii), distal movement of the forcerelease mechanism 4200 causes horizontal bars 4107′ and 4107 coupled tothe spring hub 4100 to move longitudinally, thereby releasing a bar 4108coupled to the button 4106 and freeing the button 4106 to move upwardsto its second position 4106B. Thus, in the illustrated embodiment, theindicator is automatically activated upon loading of the suture portionfrom the cartridge onto the suturing instrument. In one such example,the indicator button 4106 additionally provides an audible indication tothe user as the bar 4108 is released from engagement with horizontal bar4107′. In some such embodiments, the indicator button 4106 may form theprimary mechanism for providing an audible indication.

Once the indictor is activated the suturing instrument may then beremoved from the cartridge housing as shown in FIGS. 18E and 18F. Asdiscussed previously hereinabove, the rocker 4041 enables unimpededretraction of the suturing instrument by being made to pivot out of theway of the suturing instrument 900 to return to its initial position4041A. The seat 4022 is moveable out of the tissue receiving gap 942 ofthe suturing instrument 900.

Referring still to the embodiment disclosed in FIGS. 18E and 18F, acartridge 4000 is provided that additionally allows for loading apre-tied knot onto a suturing instrument 900, for example by allowingloading, mounting or transfer of a knot deployment mechanism or knotslider 4030 onto the suturing instrument 900. In some such embodiments,as the suturing instrument 900 is retracted from the cartridge 4000after loading of the suture portion onto the suturing instrument 900,the cartridge additionally provides for a knot deployment mechanism orknot slider 4030 (that for example has a pre-tied knot mountedthere-about) to be mounted onto the suturing instrument 900 to enableretraction of the knot deployment mechanism or knot slider 4030 alongwith suturing instrument 900. In one such example as shown in FIG. 13B,the knot deployment mechanism or knot slider 4030 is detachably coupledto the cartridge housing sleeve 4011′ by a knot slider release mechanism4060. In one such example, the knot slider release mechanism comprises aresilient member, for example a snap arm 4062, as shown, where theresilient member is configured to release the knot slider 4030 from thehousing sleeve 4011′ of the cartridge housing 4010′ upon insertion of asuturing instrument 900 there-through. In one such example, the knotslider 4030 and the cartridge housing sleeve 4011′ together form thecartridge housing 4010′. The snap arm 4062 provides flexibility andallows the knot slider 4030 to pivot up and down and bend left and rightas the suturing instrument 900 is advanced through an opening or chamberwithin the knot slider 4030 and is guided into ribs defined by thecartridge housing sleeve 4011′ to be guided into the rocker 4041. In onesuch example the knot slider 4030 is releasable from the snap arm 4062upon advancement of the suturing instrument 900 within the cartridge.For example, as shown in FIG. 18C (i), the knot slider 4030 isreleasable from the snap arm 4062 upon alignment of the seat 4022 withinthe tissue receiving gap 942 of the suturing instrument 900. As such,the knot slider 4030 is decoupled from the housing sleeve 4011′ andremains mounted on the suturing instrument to enable the knot slider4030 to be retracted along with the suturing instrument 900.

In some embodiments of the present invention, for example as shown inFIGS. 19A to 19B, the knot deployment mechanism or knot slider 4030additionally comprises a feature for reducing the risk of insertion ofthe suturing instrument 900 by the user in an upside-down, or inverted,configuration. In some such embodiments, the knot slider 4030 comprisesan instrument obstructing feature such as an interlock 4020′ comprisingan arm 4020 having a closed configuration 4020A and an openconfiguration 4020B. The interlock arm 4020 is configured to beinitially in the closed configuration 4020A for preventing advancementof an inverted suturing instrument 900 into the cartridge [such ascartridge 4000 disclosed herein above]. As illustrated in FIG. 19C, asthe suturing instrument 900 is advanced in its inverted configurationinto the cartridge 4000 through the knot slider 4030, the interlock4020′ such as the interlock arm 4020 remains in its closed configuration4020A preventing further advancement of the suturing instrument 900within the cartridge 4000. More specifically, the interlock 4020′ isconfigured to engage with the flat face 921 of the suturing instrument900. The flat face 921 of the suturing instrument does not cooperatewith the interlock arm 4020 in a manner which allows the interlock arm4020 to move into its second or open position 4020B. As such, theinterlock arm 4020 remains in its closed configuration 4020A impedingadvancement of the inverted suturing instrument 900.

Furthermore, the interlock 4020′ such as the interlock arm 4020 isoperable to permit advancement of the suturing instrument 900 when it isadvanced in its regular or nominal configuration with the instrument 900being positioned in the right-side up configuration, as shown in FIG.19A. As shown in FIG. 19B, as the suturing instrument 900 is advancedfurther through the knot slider 4030, the distal portion 910 of thesuturing instrument 900 engages with the interlock arm 4020, therebymoving it into its open configuration 4020B allowing further advancementof the suturing instrument 900 within the cartridge 4000. Morespecifically, the interlock arm 4020 is configured to engage with thebevel face 923 of the suturing instrument 900 to cause the interlock arm4020 to move into the open configuration 4020B. In some embodiments, theobstructing feature, such as an interlock 4020′, is defined by the knotslider 4030. In alternate embodiments, a cartridge 4000 is providedwhere the interlock 4020′ is defined by and forms a part of thecartridge housing sleeve 4011′ instead of the knot slider 4030 [e.g. asshown in FIGS. 21C and 21D]. In one such example as shown in FIG. 21Cthe interlock arm 4020′ is formed integrally with the housing sleeve4011′. Alternatively, the interlock arm 4020′ may be detachably coupledto the housing sleeve 4011′ via a press-fit engagement therewith, forexample as shown in FIG. 21D. In some embodiments of the presentinvention, for example as shown in FIGS. 19A-19C, the interlock arm 4020comprises a pivoting connection forming a pivot arm. In some suchembodiments, the pivot arm is held in frictional engagement with aportion of the knot slider 4030, such as the external knot slider 4010 yof the cartridge housing 4010′. The pivot arm is operable to maintainclosed configuration 4020A by, for example, a component 5000, as shownin FIG. 21E. In some examples, the component may comprise an elastomericgasket such as an O-ring.

In other embodiments as shown in FIGS. 21A (i)-21B (ii) the obstructingfeature defines an obstruction feature resilient member, i.e. analternative embodiment to an interlock arm 4020. FIGS. 21A(i) and21A(ii) illustrate the alternate interlock arm in its initial closedposition 4020A, whereas FIGS. 21B(i), 21B(ii) illustrate the alternateinterlock arm 4020 in its second or open position 4020B. In theillustrated embodiment, the interlock 4020′ such as interlock arm 4020is configured to co-operate with a lock 4040 within the cartridge 4000which hold the interlock arm 4020 in its open configuration 4020B toallow the interlock arm 4020 to remain in the open configuration 4020B.This may reducing friction that may resulting from the interlock arm4020 pressing against the suturing instrument 900, when the knot slider4030 slides along the suturing instrument 900 during the procedure. Insome such embodiments, the lock 4040 comprises a friction-fit mechanismcomprising resilient friction tabs 4040′. The lock 4040 comprisingresilient tabs 4040′ is further illustrated in FIGS. 20A and 20B whichshows an interlock 4020′ comprising a button 4020″. The button 4020″ ismoveable from its first closed configuration 4020″A shown in FIG. 20A,to its second open configuration 4020″B, shown In FIG. 20B, uponadvancement of the suturing instrument 900 in its nominal or right sideup configuration, within the cartridge. The button 4020″ is then held inits second open position 4020″B by the resilient tabs 4040′. In someembodiments, the button 4020″ may be spring-biased.

In some embodiments, the knot slider 4030, once mounted on the suturinginstrument 900, is operable to be releasably coupled to a handle of thesuturing instrument. Knot slider 4030 is further releasable therefrom toslide distally along the instrument proximal portion 910 during use toenable the pre-tied knot mounted about the knot slider 4030 to bedeployed therefrom. In some embodiments, the knot slider 4030 comprisesan attachment mechanism for slidably engaging with the suturinginstrument 900. In one specific example, as shown in FIG. 22A, theattachment mechanism comprises a tail hook or knot slider arm 4034 isslidable along a portion of the suturing instrument 900 such as thewindow 965 of the suturing instrument 900. In one such example, the knotslider arm 4034 is received within a groove within an inner slider 4030x (that is held within the outer slider 4030 y) and slidable therein tobe extendable therefrom. The knot slider arm 4034 is initially in itsretracted configuration 4034A as shown in FIG. 22A, where it is heldwithin the knot slider 4030. The knot slider arm 4034 is slidable tomove into its extended position 4034B and extends out from the knotslider 4030, as shown in FIG. 22C, and engages with a distal wall 965′of the window 965 to stop the knot slider 4030 such that it ispositioned over the tissue receiving gap 942. In some such embodiments,the knot slider 4030 comprises a cover arm 4038 and slidable knot sliderarm 4034 engages the distal wall 965′ to allow the cover arm 4038 bepositioned over the tissue receiving gap 942 to allow the cover arm 4038to deflect inwards to deploy the pre-tied knot distal to the suturinginstrument 900, as illustrated in FIG. 22D. In some examples as shown inFIG. 22E, a distal portion 4034 d of the tail kook is relatively thinnerthan a proximal portion 4034 p of the knot slider arm 4034 so that itminimizes the risk of the knot slider am 4034 interfering with thesuturing instrument 900 upon advancement of the suturing instrument 900within the knot slider 4030. In some such embodiments, the proximalportion 4034 p is wider than the distal portion 4034 d to facilitateengagement of the knot slider arm 4034 with the suturing instrument 900.In some such embodiments, the inner slider FIG. 22B of the knot slider4030 comprises a suture housing 4067′ for storing suture. In one suchexample the suture housing comprises tubing that is wound about aportion of the knot slider such as a slider central post 4067. Thecentral post 4067 defines a groove 4067′ for holding the suture tube. Insome such embodiments the tubing comprises PTFE(Polytetrafluoroethylene) such as TEFLON®.

In some such embodiments, as shown in FIG. 22F as outlined previouslyherein-above, the knot slider 4030 defines a channel 4014 for receivingthe suturing instrument 900 therein. In some such embodiments, the innerslider 4030 x of the knot slider 4030 comprises a suspension spring suchas a circumferential O-ring mounted about the channel 4014 in order tofacilitate movement of the knot slider 4030 along the suturinginstrument 900. In a specific example, the O-ring comprises silicone.The O-ring provides shock absorption along the top and bottom of thesuturing instrument 900 and facilitates sliding of the knot slider 4030by decreasing the overall sliding force by allowing the suturinginstrument 900 to be in sliding contact with the O-ring. As such theO-ring allows for easier deployment force and reduces the force ofsliding and further allows the movement of the knot slider 4030 to bemore tolerant and less sensitive to bumps.

Example 5 thus includes various alternatives to features described aboveand/or additional features not previously mentioned including but notlimited to: movement of the magazine, for example the rocker, alignmentof the seat and/or rocker, reversibility-prevention features when suturehas not been loaded, coupling of the rocker to the push-rod hub,indicator for indicating loading or transfer of suture onto the suturinginstrument, interlock to prevent insertion of the suturing instrument inan incompatible orientation and features related to the knot slider.

Example 6

In additional embodiments of the present invention, as shown for examplein FIG. 23A, a cartridge 6000 is provided having a housing 6010′ forloading suture onto a suturing instrument 900 comprising a suturepassing member such as needle for example that is held within the deviceproximal portion 910. The cartridge 6000 comprises a magazine 6041defining a seat 6022 for holding an end of the suture. The seat 6022 isstructured and configured to allow a suture passing member such as aneedle to be advanced over the suture end to capture the suture end. Inthe illustrated embodiment as shown in FIGS. 23B(i) and 23B(ii), themagazine 6041 is moveable from the first position 6041A into its secondposition 6041B as shown in FIGS. 23C(i) and 23C(ii) in order to alignthe seat 6022 within the tissue receiving gap 942 of the suturinginstrument 900. The seat 6022 is moveable into alignment with the suturepassing member held within the device proximal portion 910. In thespecific example shown, the seat 6022 is laterally moveable with themagazine 6041 being pivotable to move the seat 6022 into alignment withthe suture passing member. As such the magazine 6041 defines analignment feature for aligning the seat 6022 with the suture passingmember upon insertion of a suturing instrument within the cartridge6000. In the specific example shown, as the suturing instrument isadvanced within the cartridge 6000, the distal tip 920 of the suturinginstrument 900 moves a seat interlock 6044 which for example comprises apin which prevents movement of the seat 6022 prior to insertion of thesuturing instrument 900 within the cartridge 6000 [FIG. 23B(i), FIG.23B(ii)]. More specifically, as the suturing instrument 900 is advanced,the distal portion 920 of the suturing instrument moves the seatinterlock 6044 distally which releases the magazine 6041 causing it topivot into its second position 6041B [FIG. 23C(i), FIG. 23C(ii)]. Assuch the seat interlock 6044 is configured to be automaticallydisengaged upon advancement of the suturing instrument 900 within thecartridge 6000 to allow the seat 6022 to be automatically brought intoalignment with the suture passing member 930′ upon disengagement of theseat interlock 6044. In some such embodiments as shown in FIG. 23D, theseat 6022 comprises a seat block 6024 defines a seat cavity 6022′ forholding the suture end 502 in frictional engagement therein, as shown inFIG. 23D. The seat comprises a seat post 6026 adjacent the seat cavity6022′ for retaining the suture end 502 upon advancement of the suturinginstrument within the cartridge. The seat block 6024 is operable to bemoved away from the suture passing member such as the needle 930′ uponadvancement of the needle 930′ for example upon partial actuation of thetrigger of the suturing instrument 900, to allow capture of the sutureend by the needle 930′, as shown in FIG. 23E. The seat post 6026functions to keep the suture end 502 in place by preventing the sutureend 502 to be moved distally as the seat block 6024 is moved as shown inFIG. 23E.

In some such embodiments, the seat 6022 defines a recess 6028 adjacentthe seat cavity 6022′ for receiving the suture passing member 930′, asshown in FIG. 23D. In some such examples the recess 6028 defines a bevelface configured for abutment with a bevel face of the suture passingmember such as needle 930′. As the needle 930′ is then retracted thesuture end 502 held therein is moved along with the needle 930′ into thedevice proximal portion 910. As shown in FIG. 23G, the suturinginstrument 900 is then retracted with the distal portion 920 of thesuturing instrument 900 interacting with a bevel 6045 of the magazinecausing it to move into its first position 6041A allowing the suturinginstrument 900 to be retracted. In some such embodiments, the cartridgemay comprise an alignment mechanism described in FIGS. 12A-12F.

In some embodiments, one or more of the seat 6022 and the cartridgehousing comprise a medical grade polymer such as ABS. Alternatively thecartridge comprises a medical grade metal. In one example the seat 6022comprises a metal such as stainless steel.

In alternative embodiments of the present invention, as shown in FIGS.24A(i), 24A(ii), the cartridge 700 o comprises a pivoting magazine 7021that comprises two arms 7041, 7042 with one of the arms 7042 definingthe seat 7022. As the instrument is inserted within the cartridge 7000as shown in FIG. 24A(i), it pushes arm 7041 out of the way to swing arm7042 within the tissue receiving gap of the suturing instrument 900 toalign the seat 7022 with the suturing instrument 900, as shown in FIG.24A(ii). Similarly, FIGS. 24B(i) and 24B(ii) illustrate a cartridge 7000with a pivoting magazine 7021. With reference to FIG. 24B(iii), thecartridge 7000 additionally comprises an outer sleeve 7000′ that ismoveable distally such that bevel 7001 pushes the seat 7022 to pivot itwithin the tissue receiving gap 942. Once the outer sleeve 7000′ ispulled proximally the bevel 7002 engages arm 7041 to pivot the magazine7021 to move the seat 7022 out of the tissue receiving gap 942. Inadditional alternatives, as shown in FIGS. 24C(i), (ii), a cartridge8000 is provided that comprises a cam 8041 that is moveable to move aseat 8022 within the tissue receiving gap 942.

As such Example 6 includes various alternatives to features describedabove and/or additional features not previously mentioned including butnot limited to: movement of the magazine, alignment of the seat and/ormagazine, specifically mechanisms to enable movement of the magazine toalign the seat within the tissue receiving gap of the suturinginstrument, and additionally one or more embodiments of a cartridge thatare configured to allow a suture passing member of a suturing instrumentto capture an end of the suture.

In order to load suture into a surgical suturing instrument or suturepasser, in accordance with some embodiments of the present invention asoutlined hereinabove regarding Examples 3 and 4, two events or functionstypically occur: (1) alignment of the suture portion held within thecartridge with a suture receiving feature within the surgical suturinginstrument or the suture passer and (2) insertion or transfer of thesuture portion into the suture receiving feature within the suturinginstrument or suture passer.

In some embodiments of the present invention, a cartridge configurationis provided that is fully automated—requiring a single “pump-action”user step while completing all mechanical events to load the suture intothe suturing instrument. In one such example, a user step to actuate thesuture passer trigger to load the suture may not be required.

In addition, the suture cartridge device includes a pre-tied knot andintegrated features to store the Suture limbs, which may reduce therequired user attention to manage the Suture and may help eliminate thecomplex knot-tying step required by existing devices. In some suchembodiments, a cartridge configuration is provided that contains adetachable knot slider containing a pre-tied knot and storage of thesuture.

In some embodiments the cartridge has a side slot for securing theSuture out of the way of the suture passer shaft when it is insertedinto the cartridge.

In some such embodiments, the cartridge may be constructed of MedicalGrade plastic/metal components such as ABS for the cartridge base, seat,suture lock, interlocks and other mechanical components. In someembodiments, stainless steel may be utilized for the seat, silicone inO-rings for holding the Suture. In some embodiments the suture containedin the cartridge may comprise polyethylene.

Furthermore, embodiments of the present invention as outlined hereinallow the suture end to be positioned or constrained in the followingdegrees for alignment to occur in order to allow the suture to be loadedonto the suturing instrument. The suture portion is positioned such thatit position is maintained along the X axis (lateral direction), Y-axis(vertical or up and down directions), Z axis (linear or longitudinaldirection) as well along the Y-rotational axis and the Z rotationalaxis. Further details of the alignment mechanism are provided hereinbelow.

In some embodiments of the present invention, in order to align thesuture with a suture receiving feature of the suture passer (such assuture receiving passage within suture passing member a magazinedefining a seat is provided that is operable to be mechanicallyinterlocked with the suture passer such that when the suture cartridgeis inserted over the suture passer and pressed, the magazine and thusthe seat is configured to rotate down, aligning the suture portionwithin the seat with the suture passer. In some such embodiments themagazine defining the seat, grabs onto the suture passer to align thesuture portion in the X-axis and Y-axis and constrain X-rotation andY-rotation of the Suture. Furthermore, the seat mates with and is pushedup to the suture passer to align the suture in the Z-axis.

In some embodiments, as outlined in examples 3 and 4, the magazinecomprises a feature to hold/lock the suture to the side and align itwith the suture slot in the suture passer shaft. In some embodiments asoutlined above in examples 3 and 4, a cartridge base interlock isprovided in the form of a button that the user presses to allow thecartridge base to move. Furthermore, some embodiments provide a suturelock using which the suture is manually unlocked by the user at aspecified time

In some embodiments as described herein above with reference to examples3 and 4, embodiments of the present invention provide an alignmentmechanism that comprises a magazine defining a seat that automaticallypivots into place from the top to align the suture with the suturepasser. The magazine is mechanically interlocked with the suture passersuch that when the cartridge containing the magazine that defines theseat, is inserted onto the suture passer, the geometry of the suturepasser presses a bevel on the magazine and causes the magazine and thusthe seat defined thereby, to pivot into place. In one such example theseat is a part of a rocker as outlined in further detail herein above asdiscussed in examples 3 and 4.

In some embodiments aligning of the seat using a pivoting rocker isbeneficial when the suture passer has complex features around the siteat which the suture is loaded (or otherwise) limiting the alignment ofthe seat to be purely linear. As well, the rocker is beneficial when anautomatic (without desire of user interaction to align the seat)mechanism is desired. This is because it may generally be easier to movea pivoting part through a desired displacement on an arc than a slidingpart through a desired displacement along an axis. (this is due toreduced friction/binding and increased mechanical advantaged gained in apivoting system)

In some embodiments the seat is configured such that it is defined by atubular member (seat defining member or projection) that extends outfrom the body of the magazine such as the rocker and is receivable intothe hole on the suture passer and up against the feature in the suturepasser (such as the suture passing member such as the needle) into whichthe suture is loaded. The projection that extends into the hole in thesuture passer has an interference fit with the inner walls of the holeto align the seat/suture within a repeatable tolerance zone relative tothe feature on the suture passer that receives the suture. Having thisinterference fit may reduce the tolerance stack-up of misalignment.

In some embodiments the magazine is configured such that the magazineand thus the seat defined thereby aligns perfectly with thecorresponding features on the suture passer such that the mechanismcannot possibly ever jam because the geometry does not allow that tohappen.

In some embodiments, the magazine is configured such that it has aninterference fit with reference features on the suture passer topositively align the seat defining member or projection within arepeatable tolerance zone relative to the hole that contains the suturepassing member such as the needle on the suture passer. Having thisinterference fit may reduce the tolerance stack-up of misalignment.

In some embodiments of the present invention, an alternative seat isprovided, the seat containing a cavity that has an interference fit withthe outer diameter of the needle. As described previously, the needle isthen held in the “out” position during shipping with a lock such as camlock that hooks the needle, or a trigger lock that hold the triggerslightly depressed. In a manual version, the user is required to pressthe trigger to cause the needle to move out and into the seat cavitybefore the suture is pulled. In some such embodiments, having the“Needle-out” configuration may have a reduced tolerance stackup ofmisalignment compared to the “Needle-In” configuration.

In further embodiments of the present invention, as an alternative to atop-pivoting magazine, some embodiments of the present invention mayprovide a seat that pivots inwardly from the side. Alternatively, a seatmay be provided that slides from the side(s) or from the top.Furthermore, instead of an automatic alignment seat, a magazine may beprovided that is pushed into place by the user at a specified time topush the seat into place. Furthermore, in some embodiments where themagazine comprises a rocker as described above, a button may be pressedto enable the rocker to rotate.

In some embodiments of the present invention, the alignment featurecomprises a moveable seat as outlined above. In some such embodimentsthe seat is moveable relative to the base. In other embodiments the seatis moveable relative to the chamber defined by the housing of thecartridge. In such embodiments, the seat may be automatically moveable(upon advancement of the suturing instrument within the cartridge).

In alternative embodiments a fully automatic mechanism is provided foraligning and transferring suture. In other embodiments, a moresimplified mechanical design may be provided that reduces the number ofsteps that the user is required perform in order to load the suture. Insome embodiments, the mechanical design provides one or more steps thatthe user is required to perform to load the suture.

In alternative embodiments, with reference to example 4, a push rodinterlock may be provided in the form of a button that the user pressesin order to allow the push rod to move to push the suture end into thesuturing instrument.

In some embodiments as described herein above with reference to example4, the embodiment provides for automatic decoupling of the knot slider.In alternative embodiments, the Knot Slider may be manually decoupledfrom the Cartridge Base by the user at a specified time. In some suchembodiments a visual indicator window may be provided that shows theuser when the Lobster has been loaded and when the suture Knot Slidercan be released. In some embodiments, with reference now to example 3, asimilar mechanism in the form of a visual indicator window may beprovided that shows the user when the Lobster has been loaded and whenthe suture lock may be released.

In some embodiments of the present invention a cartridge is providedthat provides an additional means for providing an indication for whenthe suture has been loaded into the suture passing member. In some suchembodiments, an interlock in the seat, i.e. a seat interlock may beprovided which senses when the suture has left the seat. Alternativelythe cartridge may provide clear or see-through components so the usercan physically see when the Suture has been loaded. Furthermore, instill a further alternative, optical sensors may be provided that detectwhen the suture has been loaded.

In still some additional embodiments, with reference to example 4,instead of a sliding tail hook on the knot slider a fixed tail hook maybe provided.

Referring again to various examples provided hereinabove, including butnot limited to examples 2, 3 and 4, embodiments of the present inventionprovide a cartridge for loading a suture onto a suturing instrument, thecartridge defining a path for insertion thereto and withdrawal therefromof the suturing instrument, the cartridge comprising: a seat forreleasably holding a portion of a suture; and a translation mechanismfor moving the seat out of a path of a suturing instrument inserted intothe cartridge to allow for withdrawal of the suturing instrument fromthe cartridge. Thus, such embodiments provide a cartridge operable tomove the seat out of the way of the suturing instrument followingloading of the suture so that the suturing instrument can be withdrawn.In some such embodiments, the seat is moveable to align with a portionof the suturing instrument to allow for loading of the suture, such thatthe seat is moveable between: a first state whereby it is notobstructing a path of the suturing instrument to permit insertion of thesuturing instrument into the cartridge; a second state in which the seatis moved into alignment with a portion of the suturing instrument, suchas a tissue receiving gap described above, to allow for loading thesuture portion onto the suturing instrument; and a third state wherebythe seat is moved out of the path of the suturing instrument to permitsubstantially unobstructed withdrawal of the suturing instrument fromthe cartridge.

As described hereinabove, some embodiment of a cartridge include amagazine comprising the seat. In some such embodiments, movement of themagazine, and thereby the seat, between the various states may beaccomplished via a rotational mechanism (such as in examples 9 and 10where the magazine comprises a rocker) or the movement may beaccomplished via a linear mechanism such as a spring biased mechanism,for example as illustrated in Example 2 above.

In accordance with a broad embodiment of the present invention a methodis provided for loading a suture onto a surgical suturing instrument,the suture comprising suture loops and terminating in a suture end. Themethod involves mounting the suture loops onto a surgical suturinginstrument positioned through the suture loops. The suture end isaligned with the suture receiving passage of the suture passing memberand suture end is transferred to the suture receiving passage of thesuture passing member. The step of aligning the suture end may involverestraining the suturing instrument with respect to the suture end. Thesuture end may be aligned by moving the suture end with respect to thesuturing passing member. In some examples, the step of aligning thesuture end may comprise moving the suture passing member with respect tothe suture end. In some embodiments the method of loading the sutureonto the suturing instrument is performed using a suture loadingapparatus such as a cartridge. The cartridge may be used to both mountsuture loops onto the surgical instrument and to align the suture endwith the suture receiving passage of the suture passing member

In a general embodiment of the present invention, a method is providedfor suturing within an inter-vertebral disc. The method involves using acartridge to load suture onto a suturing instrument, and then using thesurgical suturing instrument to deliver the suture into theinter-vertebral disc. In some embodiments, the cartridge is used to loadsuture at the point of use, for example by a physician just prior tousing the suturing instrument within a patient. In a specific example ofthe method, the suturing instrument is used to pass or insert sutureinto a region of tissue surrounding a defect within the inter-vertebraldisc and approximating the defect using the suture. In an instant ofthis example, approximating the defect involves forming a loop of suturearound the defect using the suture to provide a 360 degree approximationof the defect. After the suture is used to approximate the defect ameans is provided to secure the suture within the inter-vertebral discsuch as knot. In some embodiments, the knot comprises a pre-tied knotand is deployed after the step of approximating the defect. In aparticular example the cartridge provides a pre-tied knot.

In some embodiments the method of loading the suture onto the suturinginstrument is performed using a suture loading apparatus such as acartridge. More specifically with reference now to FIGS. 1A-1F, acartridge 100 is provided for loading suture 500 onto the suturinginstrument 900. The suture 500 comprises suture loops or pre-tied knot502 that opens into a service loop 501 comprising a tug loop 507 thatterminates in the suture end 504 held within the seat 122. Referring nowto FIG. 1F, the distal tip 920 of suturing instrument 900 is insertedthe housing 10′ through the channel 14 within the chamber 10, such thatit is positioned through the suture loops or pre-tied knot 502 mountedon the housing 10′. The distal tip 920 of the suturing instrument 900 isthen advanced distally through and past the channel 14 so that thehousing 10′ is now mounted onto the proximal portion or shaft 910 of thesuturing instrument. Since the base 120 is flexibly coupled via flexibletube 152 to the housing 10′, this allows the cartridge base 120 to bepositioned to the side and out of the way (away from the longitudinalaxis of the suturing instrument 900) to permit the suturing instrument900 to be advanced. The flexible tube 152 bends to allow the cartridgebase 120 to be kept off to the side from the path of the surgicalsuturing instrument 900 as it is advanced through the housing 10′. Thesuturing instrument 900 is positioned such that the distal tip 920 andthe neck portion 940 as well as the tissue receiving gap 942, arepositioned distal to the housing 10′.

The cartridge base 120 is then moved back towards the longitudinal axisof the suturing instrument 900 to be clipped into the surgical suturinginstrument 900. In the example illustrated in FIG. 1A-1F, the restraint25 comprises a locking recess 125 that corresponds to the shape of thesuturing instrument 900. Specifically it is a recess that is shaped toaccommodate the neck portion 940, and a segment of the proximal anddistal portions 910, 920 of the suturing instrument 900. Referring againto FIG. 1F, the cartridge base 120 is then snapped to the suturinginstrument 900. The suturing instrument 900 is received within thelocking recess 125 such that the base 120 press-fits around it. Thelocking recess 125 functions to restrain the suturing instrument to helpalign the seat 122 and thus the suture end 504 held within the with theseat 122 with the suture receiving passage 932 of the suturinginstrument 900.

As outlined previously, the cartridge base 120 additionally comprises analignment recess 130 adjacent the seat 122 to further assist in aligningthe seat 122 with the suture receiving passage 932 of the suturinginstrument 900. The alignment recess 130 is dimensioned to receive thesuture passing member 930 such as needle 930′. Once the movement of thesuturing instrument 900 is constrained or restricted by the lockingrecess 125, the needle 930′ is advanced (for example by actuating atrigger) within the alignment recess 130 such that the needle 930′ ispositioned adjacent the seat 122.

As mentioned previously, the suture is routed through the base slot 128that is in communication with the seat 122, as shown in FIG. 1B. Oncethe suturing instrument 900 is inserted within the locking recess 125(in the position shown in FIG. 1F), the base slot 128 is aligned withthe longitudinal opening 928 within the instrument proximal portion 910and with the slit 938 within the needle 930′. The suture tug loop 507that exits the cartridge 100 is then pulled (proximally) by tugging onit for to draw the suture end 504 from the seat 122 and into the alignedsuture receiving passage 932 of the suture passing member 930 toposition the suture end 504 therein. As the tug loop 507 is pulled, thesuture retention pin 165 holds a portion of the tug loop 507 to preventthe service loop 501 from being pulled out of the suture spool 160. Thesuture retaining component 165 may then be removed, releasing the suture500. In one specific example where the trigger is actuated to advancethe needle 930′ within the recess, the trigger may be released at thispoint. Once, suture end 504 is loaded onto the suturing instrument 900,the cartridge housing 10′ is then advanced proximally along theinstrument proximal portion or shaft 910, for example till the handle ofthe suturing instrument 900 and coupled there. Once the housing 10′ isadvanced proximally the flexible tube 152 is detached from the housing10′, decoupling the base 120 from the housing′ 10′. The cartridge base120 can be removed from the suturing instrument by unsnapping thecartridge base 120 from the surgical suturing instrument 900. Morespecifically, the suturing instrument 900 is decoupled from the lockingrecess 125 of the base 120.

The suturing instrument 900 is then used to pass suture 500 through aregion of tissue for example within an intervertebral disc of apatient's body to apply suture thereto, for example to close a defectwithin the inter-vertebral disc. As the suture 500 is passed through theinter-vertebral disc, the suturing instrument 900 is then pulled suchthat the suture 500 held within suture storage such as suture spool 160is payed out. The tension within the suture 500 then decouples thehousing 10′ from the instrument proximal portion or shaft 910, allowingthe housing 10′ to slide distally along the suturing instrument 900 anddeploy the pre-tied knot 502 within the inter-vertebral disc to securethe suture 500 passed through the disc.

The cartridge base 220 may be removed from the surgical instrument anddiscarded.

In accordance with an alternate embodiment of the present invention, amethod is provided for loading suture 500 onto the suturing instrument900 using a cartridge 400, as shown in FIGS. 2A-2C. The cartridgecomprises a housing 10′ (for example of the type previously described)that is detachably coupled to the base 420. The cartridge is loaded ontothe suturing instrument 900 by advancing the instrument 900 through thehousing 10′ and then through the instrument receiving recess 425′ withinthe cartridge base 420 with the spring mounted magazine 421 (orinterlock 421′) being initially positioned in its first or initialposition 421A, as shown in FIG. 4B. In some embodiments, the cartridge400 axially receives (or in other words permits axial advancement of) aportion of a suturing instrument 900 relative to the base in order toload the suture onto the suturing instrument 900. In other words, thecartridge 400 permits loading suture onto the surgical instrument 900 byallowing the surgical instrument 900 to be received axially through thecartridge 400. For example the suturing instrument 900 may be advanceddistally through the cartridge 400 or the cartridge 400 may be movedproximally along the suturing instrument). In one example, the methodprovides for front end loading of the suturing instrument 900′ using thecartridge 400.

In a particular example, as the instrument 900 is advanced distallythrough the cartridge base 420, a tapered section of the distal tip 920engages a slant or incline 923 of the interlock 421′ automaticallymoving the magazine 421 (and thus the seat 422) downwards and into thetissue receiving gap 942 of the suturing instrument 900 to align theseat 422 (and the suture end 504 held therein) with the suture receivingpassage 932, as illustrated in FIG. 2C. The spring mounted magazine 421(or interlock 421′) is now positioned in its second position 421B. Themovement of the magazine 421 into the tissue receiving gap 942, and thedistal advancement of the suturing instrument 900 through the magazine421, further functions as a restraining feature to lock or restrain thesuturing instrument 900 with respect to the cartridge 400. In someembodiments the suturing instrument 900 is slid into the cartridge 400until it stops.

Furthermore, as the magazine 421 moves downwards during distaladvancement of the suturing instrument 900, the projection 430 movesinto the shaft 910, such that bevel 434 of the projection 430 abutsagainst the needle bevel 934. This helps align the seat 422 (and sutureend 504 held releasably within the seat channel 424) with the suturereceiving passage 932 of the suturing instrument 900. Thus, the magazine321 (FIG. 2C) is automatically moved into its second position to alignthe seat 422 with the suture passing member 930 upon relative movementbetween the cartridge base 420 and the instrument 900. In someembodiments, the housing 10′ may be advanced proximally along the shaft910 until it abuts against the instrument handle, decoupling the base420 from the housing 910′. The base 420 can then be removed from thesuturing instrument 900. In some embodiments, the base 420 can beautomatically detached as the instrument 900 is withdrawn proximally andmagazine 421 moves into its initial position 421A. The pre-tied knot 502on the housing 10′ may be deployed in the manner described previouslyfor cartridge embodiments 100, 200.

Generally embodiments of the present invention as outlined herein aboveprovide a cartridge 1000 that permits axial loading of a suturinginstrument 900 for example of the type described previously herein withreference to FIGS. 3A-3O. The suturing instrument 900 particularlyprovides a challenge as the instrument 900 defines an instrument distalportion 920 and an instrument proximal portion 910 defining a tissuereceiving gap 942 there-between, where the suture passing member 930that is to be loaded with suture is held within the instrument proximalportion 910.

Thus, in order to permit axial loading of the suturing instrument 900,the cartridge 1000 provides a means for aligning the suture with thesuture passing member 930 by allowing the suture to remain out of theway of the advancing suturing instrument 900 to enable advancement ofthe instrument distal portion 920 without hindrance. Thus, the suture iskept out of the way of the suturing instrument 900 until the instrumentdistal portion 920 has advanced past the suture, allowing the suture tothen be moved into the tissue receiving gap 942 thereafter to align thesuture with the suture passing member 930 to transfer the suturetherein.

In accordance with an embodiment of the present invention, withreference now to FIG. 4A, a method of use of the cartridge 1000 isdisclosed for facilitating loading of suture 500 onto a surgicalsuturing instrument 900, for example at the point of use. In someembodiments a pivoting seat 1022 such as that defined by the rocker 1041facilitates axial loading by enabling the rocker 1041 to remain out ofway of the path of the advancing suturing instrument 900 until thetissue receiving gap 942 is positioned within the rocker cavity 1027′.Once the suturing instrument 900 is in place the cartridge 1000 enablesthe rocker 1041 to pivot down into the tissue receiving gap 942, suchthat the seat 1022 is positioned adjacent and aligned with the suturepassing member 930 such as a needle 930′.

As shown in FIG. 4A, the method provides for initially positioning thesuturing instrument 900 within the cartridge 1000. The suturinginstrument 900 is then passed axially through the cartridge 1000 toenable front end loading of the suturing instrument 900. Morespecifically, With reference to FIGS. 4A and 3C, the suturing instrument900 is inserted into the opening 1016 within the housing 1010′ and isguided by the beveled interior edge 1016′ into the channel 1014 of thecartridge housing 1010′ and advanced distally As outlined above, channel1014 extends longitudinally through the housing 1010′ and is incommunication with the base recess 1025 formed within the base 1020,forming a restraint 25. Thus, as the suturing instrument 900 is advancedthrough the cartridge 1000, it extends from the channel 1014 into theinstrument receiving groove 1025 a of the recess 1025 within the base1020 that is in communication with the channel 1014. The restraint 25constrains or limits the movement of the suturing instrument 900 in thetransverse (i.e. up and down) and lateral directions as well along alongitudinal path defined thereby. The restraint 25 enables the suturinginstrument 900 to be advanced in sliding engagement therein to maintainthe position to the suturing instrument 900 along a path that is in linewith the final position of the seat 1022 to facilitate alignmenttherewith to enable transfer of suture into a portion of the suturinginstrument. The suturing instrument 900 is then advanced further suchthat the distal portion or end 920 of the suturing instrument 900 exitsrecess 1025 a of the base 1020. More specifically, in the illustratedembodiment as shown in FIG. 4A, as the suturing instrument 900 isadvanced it passes through the instrument receiving groove 1025 a of thebase 1020 [Shown in FIG. 3E] into the rocker recess 1027 of the base1020, until it is received within the distal groove portion 1048 of therocker 1041. As such the suturing instrument 900 is positioned adjacentthe suture 500 held within the suture groove 1025 b [Also shown in FIG.3D]. As outlined previously, the suture 500 is held within the cartridge1000 such that the suture end 504 is held within the seat 1022 fromwhere it exits into the pivot recess or cavity 1027 and is routed alongthe suture groove 1025 b of the base recess 1025.

Referring again to FIG. 4A, the distal portion 920 of the suturinginstrument 900 is initially received within the distal groove portion1048 of the rocker groove 1044, with the rocker 1041 being in itsinitial or first position 1041A. As shown in FIG. 4B, upon advancementof the suturing instrument 900, the distal surface of the distal tip 920then contacts and engages the bevel surface 1043 of the groove 1044along the rear wall of the of the distal groove portion 1048 Theinstrument distal tip engages the bevel face 1043 exerting a forcethere-against to enable the rocker 1041 to move from its first positioninto its second position 1041B, as shown in FIGS. 4C (i), 4C(ii) and4C(iii). More specifically, the distal portion 920 of the suturinginstrument 900 is advanced with a sufficient force to enable the rocker1041 to disengage from a location within the rocker recess 1027 where itis held in place in its initial position 1041A, as shown in FIG. 4A, forexample by frictional engagement or a tab.

With reference again to FIG. 4C(i), 4C(ii), 4C(iii), once rocker 1041 isreleased from engagement, it starts to pivot down. As the rocker 1041pivots into position the proximal portion 910 of the suturing instrument900 is received into the proximal groove portion 1046. The pivotalmovement of the rocker 1041 enables the suturing instrument 900 to beloaded axially by allowing the distal end 920 to advance past the seat1022 of the rocker 1041 before the rocker 1041 pivots down into thetissue receiving gap 942 such that the seat 1022 is now positionedwithin the tissue receiving gap 942 of the suturing instrument 900. Asshown in FIG. 4D, the surgical suturing instrument 900 is then continuedto be advanced into the base 1020, until the suture passing member 930such as the needle 930′ is in abutting contact with the seat 1022. Oncethe needle 930′ abuts the projection 1030, it halts the movement of thesuturing instrument 900 with respect to and within the cartridge 1000.More specifically, as shown in FIG. 4D and earlier with reference toFIG. 3M, the bevel face 934 of the needle 930′ is in abutting contactwith bevel face 1034 of the projection 1030 that defines the seat 1022such the needle slot 938 and the shaft slot 928 [behind the needle 930′and the projection 1030 that forms the seat 1022] are in line with andadjacent the seat slot 1028. The shaft slot 928 and the needle slot 938are visible in FIGS. 1D and 1E, discussed earlier.

In some embodiments of the present invention, in order to align thesuture 404 with a suture receiving feature of the suturing instrument900 (such as suture receiving passage 932 within suture passing member930) a magazine in the form of a rocker 1041 is provided that isoperable to be mechanically interlocked with the suturing instrumentsuch that when the suture cartridge is inserted over the suturinginstrument and pressed, the rocker 1041 is configured to rotate down,aligning the suture end 504 with the suturing instrument. In some suchembodiments the rocker 1041 grabs onto the suturing instrument 900 toalign the suture end 504 in the X-axis (laterally) and Y-axis(transverse/vertical or up and down directions and constrains therotation the suture end in the X and Y rotational directions.Furthermore, the rocker 1041 mates with and is pushed proximally up tothe suturing instrument 900 to align the Suture in the Z-axis (linear orlongitudinal directions).

As outlined previously up until this point the interlock 1050 remains inits initial locked position 1050A which ensures that the base 1020remains coupled to the housing 1010′ as shown in FIGS. 5A and 5C Asfurther illustrated in FIG. 5B, in this position the interlock arms 1056are positioned axially adjacent the locking arms 1026 of the base andprevent the movement of the base 1020 relative to the housing 1010′. Assuch the locking arms 1026 of the base 1020 are in engagement with theinterlock arms 1056. However, one the seat 1022 and thus the suture end504 has been aligned with the needle 930′ the cartridge 1000 enablesdirect transfer of the suture end 504 into the needle 930′ using thehousing 1010′. In other words the seat 1022 is in alignment with andadjacent the bevel face 934 of the needle 930′ the suture end held in aforce fit inside the seat 1022 can then be transferred into the needle930′ (FIGS. 3M and 4D). As shown in FIGS. 6A and 6B, the interlock 1050is then moved from its locked position 1050A to its unlocked position1050B to disengage the housing 1010′ [which defines a suturetransferring component 1011 as discussed previously herein] from thebase to transfer the suture onto the suturing instrument 900. Morespecifically, the housing 1010′ and as such the suture transferringcomponent 1011 defined thereby, is detached from the base 1020 allowingthe housing 1010′ to be pulled back such that the suture end 504 istransferred into the needle 930′, as shown in FIG. 7A. The detached base1020 may be removed thereafter as shown. As such the cartridge 1000 ofthe present embodiment allows suture to be independently transferredfrom the cartridge 1000 into the suture passing instrument 900. Inadditional embodiments, where suture loops that form a partiallypre-tied knot may be mounted about the housing 1010′, the housing 1010′additionally provides for loading a partially pre-tied knot on thesuturing instrument 900.

In some embodiments once the suture end 504 has been loaded into theneedle the housing 1010′ may then be removed. In other embodiments wherethe housing provides a partially pre-tied knot and/or carries excesssuture therein for example in a spool, the housing 1010′ may remainmounted on the instrument proximal portion 910 to retain the partiallypre-tied knot and or excess suture on the suturing instrument 900. Inthe embodiment illustrated in FIGS. 7A-7E, the suture lock 1060 may bedisengaged to allow the housing 1010′ and as such the suturetransferring component 1011 defined thereby to be disengaged with thesuturing instrument 900 after the suture end 504 has been loaded ontothe suturing instrument 900. With reference now to FIGS. 7A-7B, 7E whichillustrate the lock in its initial locked configuration 1060A. Asdiscussed previously, herein in the initial locked configuration 1060A,the suture 500 is routed through the suture lock engaging component 1062of the housing 1010′, and the suture lock 1060 is press fit in thesuture lock engaging component 1062 thereby pressing the suture 500between the teeth 1064 of the suture lock 1060 and corresponding teeth1064′ of the suture lock engaging component 1062, and as such the suture500 is coupled to the housing 1010′. In order to release the lock 1060,the lock is the moved into its second position 1060B as shown in FIGS.7D and 7F, moving the teeth 1064, 1064′ out of engagement with oneanother and releasing the suture held therein. The housing 1010′ andthus the suture transferring component 1011, may then be removed fromthe suturing instrument 900.

Thus, embodiments of the present invention provide a cartridge 1000 thatprovides a means to load suture into a suture passing instrument of thetype as described herein (such as suturing instrument 900) having aninstrument proximal portion 910 and an instrument distal end 920defining a tissue receiving gap 942 there-between. The currentembodiment additionally facilitates automatic alignment of suture 500(for example end 504 of the suture 500) by allowing the rocker 1041 topivot into the tissue receiving gap upon engagement with the instrumentdistal end 920 as it is being advanced into the cartridge 1000.

As such in terms of general overview of the embodiment described hereinabove in Example 3, in order to facilitate insertion of the sutureportion held within the cartridge, alignment of the suture portion musthave occurred and three basic mechanical events are configured to takeplace (i) an applied force on the Suture relative to the Suture Passerin one direction [for example proximally]. (ii) Relative motion betweenSuture and Suture Passer in the same direction (iii) Relative motionbetween Suture and Seat in the opposite direction.

In some such embodiments, a suture cartridge is provided that thatexerts a force on the end of the suture to load it into the surgicalsuturing instrument or the suture Passer. All mechanical events achievedby the suture cartridge device are obtained in a single “pump’ actionperformed by the user and in some embodiments may not require actuationof the suture passer (suturing instrument) trigger. {In some suchembodiments the single “pump’ action maybe likened to that of a shotgunloading action.

As such in some embodiments of the present invention, a suture cartridgeis provided that uses a pulling force on the end of the suture to loadit into the suture passer as outlined in example 3 herein above. In someembodiments, the pull method may be used to insert suture into a suturepasser that would allow space for a generally straight-line pull of thesuture in the direction of loading. In some situations the pull methodmay be used when it is required that the suture stay managed/in tensionthroughout the loading procedure.

In some embodiments, the seat locks onto a limb. The mechanical eventsto insert the suture occur in the following ways: (1) to apply the forceto the end of the suture, the strand of suture is pulled in the middleby a means of grasping the strand with the Suture Lock. (2) To achieverelative motion between the suture and suture passer, the suture passeris fixed with respect to the suture, such that when the applied pullingforce is exerted onto the Suture, the suture passer stays still and thesuture moves towards and into the suture passer. (3 to achieve relativemotion between the suture and seat (in the Suture Cartridge), the seatis also fixed with respect to the Suture, such that when the appliedpulling force is exerted onto the Suture, the seat stays still and thesuture moves away from and out of the seat.

In some embodiments, a pull insertion mechanism is provided that has asuture lock which is a piece that can move independently from thecartridge base and the suture passer that holds the suture proximally tothe seat and is moved away from the seat, thus pulling the suture andcreating the required force and relative motion.

In some embodiments, the suture lock automatically decouples from thecartridge base once the seat has fully aligned the suture (sutureportion) with the suture passer. This is done by way of an interlockthat prevents the Suture lock from moving relative to the cartridge baseuntil the full alignment step has occurred (i.e. prevents the suturefrom being pulled before it is fully aligned).

In some embodiments, the pull insertion mechanism comprises a sutureLock that automatically unlocks from the suture once the suture (e.g.suture end) has been successfully loaded into the suture passer. As suchunlocking of the suture allows the suture passer to then pass the suturefreely. In some examples, the unlocking is performed by way of aninterlock which prevents unlocking to occur until the point at which thesuture is successfully loaded into the suture passer. In one suchexample, the suture lock interlock may be force/displacement based usinga spring to ensure that a given amount of force is exerted on the sutureto obtain a given displacement of the suture lock. In some embodiments,the force may be calibrated to be much greater than the maximumtheoretical/empirically derived force required to successfully load theSuture. Once this force is achieved, a certain displacement may also beachieved causing the interlock to unlock the suture.

In some such embodiments, a pre-tied knot is provided on a knot sliderwhich is integrated with a suture lock and houses the suture strands.The knot Slider remains on the suture passer after the suture cartridgeis actuated to load the suture into the suture passer and functions torelease the suture knot to the surgical site once the suture passer isused.

In accordance with an embodiment of the present invention, withreference now to FIG. 9A[i]-10D[ii], a method of use of the cartridge2000 is disclosed for facilitating loading of suture 500 onto a surgicalsuturing instrument 900, for example at the point of use. In someembodiments a pivoting seat 1022 such as that defined by the rocker 1041facilitates axial loading by enabling the rocker 1041 to remain out ofway of the path of the advancing suturing instrument 900 until thetissue receiving gap 942 is positioned substantially within the rockercavity 1027′. Once the suturing instrument 900 is in place the cartridge1000 enables the rocker 1041 to pivot down into the tissue receiving gap942, such that the seat 1022 is positioned adjacent and aligned with thesuture passing member 930 such as a needle 930′. The cartridge 2000additionally provides a suture transferring component 2011 fortransferring the suture end 504 from the seat 1022 into the suturereceiving recess 932 of the suturing instrument 900. The cartridge 2000additionally provides a knot slider 2030 that permits loading of apre-tied knot 502 onto the suturing instrument 900.

In some embodiments], the method provides for initially positioning thesuturing instrument 900 within the cartridge 2000. The method isdescribed in reference to the advancement of the suturing instrument 900within the cartridge 2000. However, in some such embodiments thecartridge 2000 is loaded onto the suturing instrument 900 via a proximalmovement of the cartridge 2000 over the suturing instrument 900. As suchthe suturing instrument 900 the cartridge 2000 are moveable relative toone another.

With reference now to FIG. 9A[i], the cartridge 300 is loaded proximallyover the suturing instrument 900, with the suturing instrument 900 beingpassed axially through the cartridge 3000 to enable front end loading ofthe suturing instrument 900. More specifically, the suturing instrument900 is inserted through the chamber 1010 of the housing 1010′ defined bythe knot slider 2030. The suturing instrument is guided by the beveledinterior edge 2016′ of the opening 2016 into the channel 2014 of theknot slider (FIG. 8D and FIG. 9A [iii]), and as such mounting the knotslider 2030 and the pre-tied knot mounted onto the suturing instrument.As the suturing instrument 900 is advanced further it is received withinthe instrument receiving groove 2025 a of the base recess 2025 withinthe base 2020. The base recess 2025 and the channel 1014, function asthe restraint 25 to constraint or limit the movement of the suturinginstrument 900 in the transverse (i.e. up and down) and lateraldirections as well along a longitudinal path defined thereby. Therestraint 25 enables the suturing instrument 900 to be advanced insliding engagement therein to maintain the position to the suturinginstrument 900 along a path that is in line with the final position ofthe seat 1022 to facilitate alignment therewith to enable transfer ofsuture into a portion of the suturing instrument. The instrumentreceiving groove 2025 a guides the suturing instrument into the rockerrecess 1027. As outlined previously, the suture 500 is held within thecartridge 2000 such that the suture end 504 is held within the seat 1022from where it exits into the pivot recess or cavity 1027 and is routedalong the suture groove 1025 b of the base recess 1025. As such thesuturing instrument 900 is positioned adjacent the suture 500 heldwithin the suture groove 1025 b, also shown in (FIGS. 8F[i], 8F[ii]).

Referring again to FIG. 9A[i],[ii], the distal portion 920 of thesuturing instrument 900 is initially received within the distal grooveportion 1048 of the rocker groove 1044, with the rocker 1041 being inits initial or first position 1041A. Upon advancement the instrumentdistal tip 920 contacts and engages the bevel surface 1043 along therear wall of the of the distal groove portion 1048 exerting a forcethere-against to move the rocker 1041 to rom its first position 1041Ainto its second position 1041B, as shown in FIGS. 9B[i],[ii]. Morespecifically, the distal portion 920 of the suturing instrument 900 isadvanced with a sufficient force to enable the rocker 1041 to disengagefrom the friction tab 2029 within the rocker recess 1027 where it isheld in place in its initial position 1041A, as shown in FIG. 9A[i].

With reference again to FIGS. 9B[i], 9B [ii], once rocker 1041 isreleased from engagement within the rocker recess 1027, it starts topivot down into the rocker cavity 1027′. As the rocker 1041 pivots intoposition the proximal portion 910 of the suturing instrument 900 isreceived into the proximal groove portion 1046. The pivotal movement ofthe rocker 1041 enables the suturing instrument 900 to be loaded axiallyby allowing the distal end 920 to advance past the seat 1022 of therocker 1041 before the rocker 1041 pivots down into the rocker cavity1027′ that corresponds to the tissue receiving gap 942 such that theseat 1022 is now positioned within the tissue receiving gap 942 of thesuturing instrument 900.

In some embodiments of the present invention, in order to align thesuture 504 with a suture receiving feature of the suturing instrument900 (such as suture receiving passage 932 within suture passing member930) a magazine in the form of a rocker 1041 is provided that isoperable to be mechanically interlocked with the suturing instrumentsuch that when the suture cartridge is inserted over the suturinginstrument and pressed, the rocker 1041 is configured to rotate down,aligning the suture end 504 with the suturing instrument. In some suchembodiments the rocker 1041 grabs onto the suturing instrument 900 toalign the suture end 504 in the X-axis (laterally) and Y-axis(transverse/vertical or up and down directions and constrains therotation the suture end in the X and Y rotational directions.Furthermore, the rocker 1041 mates with and is pushed proximally up tothe suturing instrument 900 to align the suture in the Z-axis (linear orlongitudinal directions).

As shown in FIG. 9B[i],[ii], the surgical suturing instrument 900 isthen continued to be advanced into the base 2020, upto/until the suturepassing member 930 such as the needle 930′ is in abutting contact withthe seat 1022. Once the needle 930′ abuts the projection 1030, it haltsthe movement of the suturing instrument 900 with respect to and withinthe cartridge 1000. More specifically, as shown in FIG. 4D and earlierwith reference to FIG. 3M, the bevel face 934 of the needle 930′ is inabutting contact with bevel face 1034 of the projection 1030 thatdefines the seat 1022 such the needle slot 938 and the shaft slot 928[behind the needle 930′ and the projection 1030 that forms the seat1022] are in line with and adjacent the seat slot 1028. The shaft slot928 and the needle slot 938 are visible in FIGS. 1D and 1E, discussedearlier.

As outlined previously up until this point the interlock 2050 remains inits initial locked position 1050A which ensures that the base 1020remains coupled to the housing 1010′ as shown in FIGS. 9A[i],9A[ii]. Asfurther illustrated in FIGS. 9C[i], 9C[ii], in this position theinterlock arm 2056 is positioned axially adjacent and distal to the base2020. The interlock arm prevents the movement of the base 2020 relativeto the housing 2010′. However, as the seat 1022 moves into the rockercavity 1027′ of the rocker recess 1027 (and thus the suture end 504 hasbeen aligned with the needle 930′) the rocker bar 2055 moves theinterlock tab 2054 adjacent the base wall 2054′ to be positioned out ofway of the interlock 2050. As shown in FIGS. 9D[i], 9D[ii], theinterlock 2050 is then moved from its locked position 2050A to itsunlocked position 2050B to disengage the base 2020 from the housing1010′ [which defines a suture transferring component 1011 as discussedpreviously herein]. This allows the base 2020 and the knot slider 2030attached thereto to slide distally as the housing sleeve 1011′ is pulledproximally (FIGS. 9E[i],9E[ii]). In the illustrated example, theinterlock 2050 is moved by the user.

Upon relative movement of the suture transferring component 1011proximally relative to the base 2020, the base 2020 moves distally andpresses against the push sleeve hub 2012 that moves distally within thesleeve cavity 2012′. As the push sleeve hub 2012 is biased towards thebase 2020 via a spring mechanism [that comprises two springs 2013], itfunctions to push the push rod hub 2057 upon translation of the suturetransferring component 2011 with respect to the base 2020. The push rodhub 2057 translates proximally within push rod cavity 2057′ (FIGS. 9Bii,9E[ii]) causing the longitudinally extending wire 2053′ to translateproximally within the wire channel 2053 in communication with the seat1022 to push the suture end 504 held within the seat 1022 into thesuture receiving passage 932 of the suturing instrument 900.

As the base 2020 is advanced distally, the knot slider 2030 is moveablewith base 2020 the knot slider 2030 is moveable distally along the knotslider recess 2018 within the housing sleeve 2011′ upon distal movementof the base 2020 within the housing sleeve 2011′. However, the wall ofthe housing sleeve 1011′ adjacent the tapered inner wall 2019 [FIG. 8B]of the knot slider recess 2018 functions as a stop to prevent furtherdistal movement of the knot slider 2030 to disengage snap arms 2042 ofthe base 2020 from the snap grooves of the knot slider 2030, as shown inFIG. 9F. As such the knot slider release interlock 2033 is disengagedreleasing the knot slider 2030. In additional embodiments, where sutureloops that form a partially pre-tied knot may be mounted about thehousing 1010′, the housing 1010′ additionally provides for loading apartially pre-tied knot on the suturing instrument 900.

In some embodiments the suture is contained within tubing [for exampleinside a polytetrafluoroethylene (PTFE) tube] mounted on the inside theknot slider 2030 [FIG. 11D], the cartridge additionally provides forloading or mounting the suture limbs within the knot slider 2030 on thesuturing instrument 900 along with the partially pre-tied knot.

In some embodiments once the suture end 504 has been loaded into theneedle the housing 1010′ the cartridge 2000 may then be removed and maybe pulled proximally. As such in some embodiments the cartridge 2000 isloaded onto the suturing instrument 900 and removed thereafter using apumping action. The relative movement of the suturing instrument withrespect to the cartridge 2000 is in a proximal direction. As thesuturing instrument 900 is pulled proximally the knot slider 2030remains mounted thereon and is removed with the suturing instrument 900(as shown in FIG. 10A). As the suturing instrument 900 is retracted thedistal head 920 interacts with the bevel face 1043′ of the rocker 1041(FIG. 10B). This enables the rocker 1041 to move out from the tissuereceiving gap 942 allowing the suturing instrument 900 to be removed,without hindrance as shown in FIG. 10C.

The knot slider arm 2034 is slidable along the instrument window orgroove 965 in said inner position 2034A. The knot slider arm 2034 mayremain in its initial position 2034A as it is slid proximally along theinstrument proximal portion or shaft 910, for example to be attachedwith a handle portion 960 of the instrument 900 [shown in FIG. 11A].Once the instrument 900 has been used to pass suture the tissue theinstrument 900 may be used thereafter to deploy the pre-tied knot 502.As the instrument 900 is pulled back proximally after suturing the knotslider 2030 disengages from the handle portion of the suturinginstrument and slides distally along the shaft proximal portion of thesuturing instrument 900. As shown in FIG. 11B, as the knot slider slidesdistally along the shaft 910 it engages with a front wall 965′ of theshaft groove 965, causing the knot slider arm 2034 to move out from theslider groove 2036 into said external position 2034B to enablepositioning of said knot slider 2030 over the tissue receiving gap 942[FIG. 11C] such that a cover arm 2038 of the knot slider is positionedover the tissue receiving gap 942. This enables deployment of thepre-tied 502 from the knot slider 2030 while maintaining engagement ofthe knot slider 2030 with the suturing instrument 900 and as suchprevents the pre-tied knot from falling in or getting caught in thetissue receiving gap 942.

Thus, embodiments of the present invention additionally provide acartridge 2000 that provides a means to load suture into a suturepassing instrument 900 of the type as described herein having aninstrument proximal portion 910 and an instrument distal end 920defining a tissue receiving gap 942 there-between. The currentembodiment additionally facilitates automatic alignment of suture 500(for example end 504 of the suture 500) by allowing the rocker 1041 topivot into the tissue receiving gap upon engagement with the instrumentdistal end 920 as it is being advanced into the cartridge 1000.Furthermore, cartridge 2000 provides a suture transferring component2011 to transfer suture into the suture passing member and additionallyprovides a knot slider 2030 to mount a pre-tied knot 502 onto thesuturing instrument 900.

As such in terms of general overview of the embodiment described hereinabove in example 4, in order to facilitate insertion of the sutureportion held within the cartridge, alignment of the suture portion musthave occurred and three basic mechanical events are configured to takeplace (i) an applied force on the Suture relative to the Suture Passerin one direction [for example proximally]. (ii) Relative motion betweenSuture and Suture Passer in the same direction (iii) Relative motionbetween Suture and Seat in the opposite direction.

In some such embodiments, a suture cartridge is provided that thatexerts a force on the end of the suture to load it into the surgicalsuturing instrument or the suture Passer. All mechanical events achievedby the suture cartridge device are obtained in a single “pump’ actionperformed by the user and in some embodiments may not require actuationof the suture passer (suturing instrument) trigger. {In some suchembodiments the single “pump’ action maybe likened to that of a shotgunloading action.

In some such embodiments, a suture cartridge is provided that uses apushing force on the end of the suture to load it into the suture passeras outlined in example 4 herein above. In one such example the cartridgeapplies a direct pushing force to the suture to load it onto the suturepasser.

In some embodiments, the cartridge comprises a push rod which is a partof the cartridge independent from the seat and suture passer. It is apiece that exists inside the seat and upon actuation presses against theend of the suture to push it forwards in the seat.

In some embodiments, the mechanical events to insert the suture occur inthe following ways: (i) to apply the force to the end of the suture aflexible, moveable push rod exists in an S-shaped lumen that exists inthe seat. The push rod has a tip that contacts the suture. (ii) Toachieve relative motion between the suture and suture passer, the suturepasser is fixed with respect to the Suture, such that when the appliedpushing force is exerted onto the suture, the suture passer stays stilland the suture moves towards and into the suture passer. (iii) toachieve relative motion between the suture and seat (in the suturecartridge), the seat is also fixed with respect to the push rod andsuture, such that when the applied pushing force is exerted onto thesuture, the seat stays still and the suture moves away from and out ofthe seat.

In some embodiments, once insertion of the suture has been achieved, apart of the cartridge that contains the suture limbs (the knot slider)detaches from the cartridge and remains attached to the suture passer.In some embodiments the push method can be used when a high loadingforce is required.

In some embodiments, the cartridge mechanism comprises a push rod thatis a piece that can move independently from the cartridge base, seat andsuture passer and it is a piece that exists inside the seat and uponactuation presses against the end of the suture to push it forwards inthe Seat.

In some embodiments, the push insertion mechanism is configured suchthat the push rod pushes the suture once the seat has fully aligned theSuture with the suture passer. This may be done by way of a series ofinterlocks that prevent the push rod from moving relative to the seatuntil the full alignment step has occurred (i.e. prevents the suturefrom being pushed before it is fully aligned). Interlocks: 1: RockerInterlock to prevent the rocker from moving until shaft is inserted [tabor detent 2029 FIG. 8C]. 2: Rocker Geometry: being such that it preventsseat member from contacting shaft during rocker rotation (For examplebevel 1043 in FIG. 9A[i] of the rocker and its location andconfiguration in reference to the seat ensures that the seat does notcontact the shaft as the instrument is advanced). 3: Push Rod Interlock:to prevent the push rod from moving before the seat is aligned with theneedle. 5: Push Spring: in some embodiments the push rod is actuatedwith a spring (as outlined above in example 4) to ensure that a givenamount of force was being exerted on the suture for a given displacementof the push rod. This force would be calibrated to be much greater thanthe maximum theoretical/empirically derived force required tosuccessfully load the Suture. Once this force was achieved, a certaindisplacement would also be achieved and the interlock would unlock theSuture.

In some embodiments, as outlined previously herein above the cartridgeis configured for containing a pre-tied knot on a knot slider which alsohouses the suture strands. The Knot Slider [for e.g. 2030 as describedabove) automatically detaches from the cartridge Base and remains on thesuture passer after the suture cartridge is actuated. The knot sliderfunctions to release the suture knot to the surgical site once thesuture passer is used.

In some embodiments interlock may be provided. For example: Knot sliderrelease interlock (for example knot slider release interlock 2033 asdescribed above) which prevents the knot slider form releasing until thesuture has been loaded into the needle. In some embodiments, there maybe an additional suture retention interlock that prevents the suturelimb from moving until the shaft is removed from the cartridge.

Suture Storage: As outlined previously with reference to FIG. 11D, thecartridge in some embodiments stores the suture limbs within the KnotSlider inside a (polytetrafluoroethylene) PTFE tube. Furthermore, asoutlined in example 4, the cartridge comprises knot slider retentionfeatures on shaft. In some embodiments the cartridge has a Knot Sliderthat contains a tail hook that retains the knot slider on the suturepasser shaft at the end of the procedure. As outlined previously, thetail hook is enclosed within the knot slider and once the knot sliderslides to the end of the shaft, the tail hook slides out of the knotslider and hooks onto the shaft.

Thus, as described herein above, various embodiments of a cartridge, andmethods of use thereof, are disclosed. These embodiments provide acartridge for loading suture at the point-of-use onto a surgicalsuturing instrument such as a suture passing instrument or suturepasser, where the suturing instrument includes a suture passing memberonto/into which the suture is to be loaded, and where the applicationrequires/benefits from a pre-tied knot. In some embodiments a sutureloading cartridge is provided with a feature for securing a pre-tiedknot with the ability to deploy the pre-tied knot onto the suture passer(for example by passing the suturing instrument through a chamber of thecartridge that has the knot tied about it), as well as a second featurefor aligning a suture end with the suture passing member of the suturepasser to facilitate loading of the suture onto/into the suture passingmember. In some embodiments the second feature for aligning the suturemay be movable with respect to the first feature (so that the suturepasser can be inserted into the cartridge through the pre-tied knotafter which a suture end loaded into the cartridge can be brought intoalignment with the suture passing member).

In one broad aspect, embodiments of the present invention provide acartridge for loading a suture onto a suturing instrument, the cartridgedefining a path for insertion thereto and withdrawal therefrom of thesuturing instrument, the cartridge comprising: a seat for releasablyholding a portion of a suture; and a translation mechanism for movingthe seat out of a path of a suturing instrument inserted into thecartridge to allow for withdrawal of the suturing instrument from thecartridge.

In another broad aspect, embodiments of the present invention provide acartridge for loading a suture onto a suturing instrument, the cartridgecomprising: a seat for releasably holding a portion of a suture; and analignment feature for facilitating alignment of the seat with a suturinginstrument to permit transfer of the suture portion from the seat ontothe suturing instrument.

In still an additional broad aspect, embodiments of the presentinvention provide A cartridge for loading suture onto a suturinginstrument, the cartridge comprising: a seat for holding a portion ofthe suture; and an instrument retention mechanism configured to allowadvancement of a suturing instrument into the cartridge and to preventpremature retraction therefrom.

In a further broad aspect embodiments of the present invention comprisea cartridge for loading a suture onto a suturing instrument, thecartridge comprising: a seat for releasably holding a portion of asuture to enable transfer of the suture onto the suturing instrument;and an indicator for indicating transfer of the suture portion onto thesuturing instrument.

In still an additional embodiment, a cartridge is provided for loadingsuture onto a suturing instrument, the cartridge comprising: a seat forholding a portion of a suture; and an obstructing feature having aclosed configuration and an open configuration, the obstructing featurebeing configured to be initially in the closed configuration forpreventing advancement of an inverted suturing instrument into thecartridge, and to be moveable into the open configuration upon insertionof the suturing instrument into the cartridge in a nominal orientation.

In still another broad aspect, embodiments of the present inventionprovide a cartridge for loading suture onto a suturing instrument, thecartridge comprising: a seat for releasably holding a portion of thesuture; an alignment feature for aligning the seat with a portion of thesuturing instrument; a suture insertion mechanism that is actuatable toinsert the suture portion from the seat onto the suturing instrument;and a delay interlock to prevent actuation of the suture insertionmechanism prior to alignment of the seat with the portion of thesuturing instrument.

In still another broad aspect, embodiments of the present inventionprovide a cartridge for In still a further broad aspect, embodiments ofthe present invention provide a cartridge for loading a pre-tied knotonto a suturing instrument, the cartridge comprising: a cartridgehousing; a knot slider for carrying a pre-tied knot thereabout; and aknot slider release mechanism for detachably coupling the knot slider tothe cartridge housing.

In an additional broad aspect, embodiments of the present inventionprovide a cartridge for a cartridge for loading suture onto a suturinginstrument comprising a suture passing member, the cartridge comprisinga seat for holding an end of the suture, the seat being structured andconfigured to allow a suture passing member to be advanced over thesuture end to capture the suture end.

The embodiments of the invention described above are intended to beexemplary only. The scope of the invention is therefore intended to belimited solely by the scope of the appended claims.

It is appreciated that certain features of the invention, which are, forclarity, described in the context of separate embodiments, may also beprovided in combination in a single embodiment. Conversely, variousfeatures of the invention, which are, for brevity, described in thecontext of a single embodiment, may also be provided separately or inany suitable subcombination.

Although the invention has been described in conjunction with specificembodiments thereof, it is evident that many alternatives, modificationsand variations will be apparent to those skilled in the art.Accordingly, it is intended to embrace all such alternatives,modifications and variations that fall within the broad scope of theappended claims. All publications, patents and patent applicationsmentioned in this specification are herein incorporated in theirentirety by reference into the specification, to the same extent as ifeach individual publication, patent or patent application wasspecifically and individually indicated to be incorporated herein byreference. In addition, citation or identification of any reference inthis application shall not be construed as an admission that suchreference is available as prior art to the present invention.

We claim:
 1. A cartridge for loading a suture onto a suturing instrumentcomprising a suture receiving portion, the cartridge comprising: ahousing, wherein the housing comprises a channel for insertion theretoand withdrawal therefrom of the suturing instrument wherein the channeldefines a channel longitudinal axis; and a rocker configured to pivotwithin the housing, wherein the rocker comprises: a seat for releasablyholding a portion of the suture; and a suture transfer mechanismcomprising a push rod that is actuatable to transfer the portion of thesuture from the seat onto the suture receiving portion along the channellongitudinal axis.
 2. The cartridge of claim 1, wherein the rockerfurther comprises a translation mechanism for aligning the seat with thesuturing instrument.
 3. The cartridge of claim 2, wherein thetranslation mechanism moves the seat out of a path of the suturinginstrument for withdrawal of the suturing instrument from the cartridge.4. The cartridge of claim 2, wherein the translation mechanism comprisesa rotational mechanism.
 5. The cartridge of claim 1, wherein the seat ismoveable to align with the suture receiving portion.
 6. The cartridge ofclaim 1, wherein the cartridge comprises a projection defining the seat.7. The cartridge of claim 6, wherein the projection comprises one ormore interference features for engaging with an interior of a portion ofthe suturing instrument for aligning the seat with a portion of thesuturing instrument.
 8. The cartridge of claim 1, wherein the seatdefines a seat cavity for retaining the portion of the suture, theportion of the suture comprising a suture end.
 9. The cartridge of claim1, further comprising an instrument retention mechanism configured toallow advancement of the suturing instrument into the cartridge and toprevent premature retraction therefrom.
 10. The cartridge of claim 9,wherein the instrument retention mechanism comprises a lock.
 11. Thecartridge of claim 10, wherein the cartridge comprises a lock releasemechanism for disengaging the lock upon transfer of the portion of thesuture onto the suturing instrument.
 12. The cartridge of claim 11,wherein the lock release mechanism is manually operable to disengage thelock.
 13. The cartridge of claim 11, wherein the lock release mechanismis configured to automatically disengage the lock upon transfer of theportion of the suture onto the suturing instrument.
 14. The cartridge ofclaim 1, wherein the rocker defines a channel in communication with theseat for allowing movement of the push rod therethrough for transferringthe portion of the suture from the seat into the suturing instrument.15. A suturing kit, comprising at least one suturing instrument and thecartridge of claim
 1. 16. The kit of claim 15, wherein the suturinginstrument comprises: a proximal portion; a distal portion coupled tothe proximal portion; and a tissue receiving gap defined between theproximal portion and the distal portion for receiving a tissue to besutured.
 17. The kit of claim 16, wherein the seat is moveable into thetissue receiving gap to align the seat with a portion of the suturinginstrument.
 18. The kit of claim 17, wherein the seat is moveable out ofthe tissue receiving gap to allow for withdrawal of the suturinginstrument from the cartridge.